Dental careers and fluoridation in Kentucky

1-http://fluoridealert.org/researchers/states/kentucky/

2-3-School fluoridation studies in Elk Lake, Pennsylvania, and Pike County, Kentucky–results after eight years.

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1229128/?page=1

4-American Association for Dental Research Policy Statement on Community Water Fluoridation

http://journals.sagepub.com/doi/abs/10.1177/0022034518797274

5- Ground-Water Quality in Kentucky: Fluoride – University of Kentucky

http://www.uky.edu/KGS/pdf/ic12_01.pdf

6-Kentucky Oral Health Program Brochure – Cabinet for Health.

https://chfs.ky.gov/agencies/dph/dmch/cfhib/Oral%20Health%20Program/beigebrochureoralhealth80107.pdf

7-

8-9-

PIIS00028177146263

98.pdf

746 JADA, Vol. 131, June 2000

Enamel fluorosis is a hypomineralization of the enamel caused by the ingestion of an amount of fluoride that is above optimal levels during enamel formation.1,2 Clinically, the appearance of enamel fluorosis can vary. In its mildest form, it appears as faint white lines or streaks visible only to trained examiners under controlled exam- ination conditions. In its pronounced form, fluo-

rosis manifests as white mottling of the teeth in which noticeable white lines or streaks often have coalesced into larger opaque areas.2,3 Brown staining or pitting of the enamel also may be present.2,3 In its most severe form, actual break- down of the enamel may occur.2,3

In recent years, there has been an increase in the prevalence of children seen with enamel fluo-

A B S T R A C T

Background. Few studies have evaluated the impact of specific fluoride sources on the prevalence of enamel fluorosis in the population. The author con- ducted research to determine attributable risk percent estimates for mild-to-moderate enamel fluorosis in two populations of middle-school–aged children. Methods. The author recruited two groups of children 10 to 14 years of age. One group of 429 had grown up in nonfluoridated communities; the other group of 234 had grown up in optimally fluoridated communities. Trained examiners measured enamel fluorosis using the Fluorosis Risk Index and meas- ured early childhood fluoride exposure using a ques- tionnaire completed by the parent. The author then calculated attributable risk percent estimates, or the proportion of cases of mild-to-moderate enamel fluo- rosis associated with exposure to specific early fluo- ride sources, based on logistic regression models. Results. In the nonfluoridated study sample, sixty-five percent of the enamel fluorosis cases were attributed to fluoride supplementation under the pre- 1994 protocol. An additional 34 percent were

explained by the children having brushed more than once per day during the first two years of life. In the optimally fluoridated study sample, 68 percent of the enamel fluorosis cases were explained by the children using more than a pea-sized amount of toothpaste during the first year of life, 13 percent by having been inappropriately given a fluoride supplement, and 9 percent by the use of infant formula in the form of a powdered concentrate. Conclusions. Enamel fluorosis in the non- fluoridated study sample was attributed to fluoride supplementation under the pre-1994 protocol and early toothbrushing behaviors. Enamel fluorosis in the optimally fluoridated study sample was attrib- uted to early toothbrushing behaviors, inappropriate fluoride supplementation and the use of infant for- mula in the form of a powdered concentrate. Clinical Implications. By advising parents about the best early use of fluoride agents, health professionals play an important role in reduc- ing the prevalence of clinically noticeable enamel fluorosis.

RISK OF ENAMEL FLUOROSIS IN NONFLUORIDATED AND OPTIMALLY FLUORIDATED POPULATIONS: CONSIDERATIONS FOR THE DENTAL PROFESSIONAL DAVID G. PENDRYS, D.D.S., PH.D.

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ARTICLE 1

Copyright ©1998-2001 American Dental Association. All rights reserved.

for enamel fluorosis.17,25 The use of infant formula in various forms, before the infant formula industry’s voluntary reduction in the fluoride content of its products, also has been associ- ated with enamel fluorosis.12,17,33

Findings from two recent stud- ies suggest that while the risk of enamel fluorosis associated with infant formula use may no longer exist for children living in nonfluoridated communities, the use of formula in the pow- dered concentrate form pre- pared with optimally fluoridated water may continue to be an enamel fluorosis risk factor.21,25

While an increasing number of studies have reported esti- mates of the relative risk or the increased likelihood of enamel fluorosis associated with specif- ic early fluoride exposures, rel- atively few investigations have evaluated the impact of a spe- cific fluoride-containing agent on the prevalence of enamel fluorosis in the population.12,15,34

This impact is a function of both the relative risk associated with a specific fluoride-contain- ing agent, as well as the preva- lence of exposure to that agent within the population. It is thought to be best measured via estimation of the attributable risk percent,35 or the percentage of all fluorosis cases that can be explained by exposure to a spe- cific fluoride-containing agent. The attributable risk, therefore, becomes an estimate of the potential reduction in cases that would occur were the asso- ciated exposure modified or eliminated. Because children may be exposed to several dif- ferent fluoride-containing agents during the tooth-devel- opment period, the most accu- rate attributable risk percent estimate for a specific fluoride-

rosis in both optimally fluoridat- ed and nonfluoridated areas of the United States.4,5 The great- est relative increase in fluorosis prevalence has occurred in non- fluoridated areas.4 Dentists and hygienists need to understand the most likely reasons for this increase. This will allow them to advise parents about the most appropriate use of fluoride to prevent caries in their children while minimizing the risk of their children developing enamel fluorosis.

Dating back to the classic research of H. Trendley Dean, it has been well-known that a concentration of approximately 1 part per million fluoride in the drinking water imparts sub- stantial caries protection with the absence of noticeable enam- el fluorosis.6-8

Since the advent of optimal water fluoridation, other pre- ventive fluoride agents have been introduced. They include ingestible fluoride supplements and fluoride toothpaste, which may be ingested by young chil- dren, although it is intended for topical use.9-11

Studies suggest that behav- iors associated with the early use of fluoride toothpaste—such as the amount of toothpaste usually used when brushing— are associated with enamel fluo- rosis in both optimally fluori- dated and nonfluoridated popu- lations in the United States and elsewhere.12-25 Studies further suggest that early fluoride sup- plements use by children living in nonfluoridated areas have been an important risk factor for enamel fluorosis.21,26-32 Not unexpectedly, the inappropriate use of fluoride supplements by children living in optimally fluoridated areas has been shown to be a strong risk factor

containing agent should be adjusted for exposure to any other fluoride-containing agents.4,35 To date, only two investigations have reported adjusted attributable risk per- cent estimates15,34; and only one of these investigations has reported these estimates along with adjusted confidence inter- vals, which gives the reader the best sense of the statistical sig- nificance of those estimates.34

That study also was the only one to have reported findings from the investigation of a U.S. population.34

A study of Canadian children who were current residents of an optimally fluoridated area reported that 72 percent of the fluorosis cases could be attrib- uted to beginning to brush teeth with fluoride toothpaste during the first two years of life.12 In this same study, 22 percent of the cases were attributed to the use of infant formula.

A study of Australian chil- dren who also resided in an opti- mally fluoridated area reported that 47 percent of the fluorosis cases could be explained by a history of swallowing toothpaste at a young age, while 55 percent of the fluorosis cases seen in this study could be explained by the early cessation of breast-feeding, with the implication that these infants were switched to the use of infant formula.15

A study of children in Connecticut who grew up in optimally fluoridated communi- ties reported that 71 percent of the cases could be attributed to “usually” brushing more than once a day and “usually” using more than a pea-sized amount of toothpaste during the first eight years.34 Twenty-five per- cent of these cases were attrib- utable to children having been

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Copyright ©1998-2001 American Dental Association. All rights reserved.

inappropriately given a fluoride supplement during the first eight years of their lives.34

Understanding attributable risk information reported in the literature is important; dentists and hygienists need to be able to provide the parents of young children with appro- priate advice regarding the early use of fluoride toothpaste and fluoride supplements. In this article, I report on results of research I performed to determine attributable risk percent estimates for mild-to- moderate enamel fluorosis in two populations of middle- school–aged children born after the 1978 fluoride supplement dosage revision36,37 and after the decision by U.S. infant for- mula manufacturers to reduce and control the fluoride content of their products38,39 (effective for those born in 1980 and after). Because comprehensive, surface-specific analyses of the relative risk percent estimates associated with enamel fluoro- sis in these two populations have been previously report- ed,21,25 key findings from those reports will be only briefly reviewed in this article.

MATERIALS AND METHODS

Detailed descriptions of the methods used in my previous investigations are published elsewhere21,25; therefore, only a brief summary follows. All study procedures involving human subjects were approved by the University of Connecticut Health Center Institutional Review Board. The study subjects consisted of mid- dle-school–aged children who had grown up in either six non- fluoridated Massachusetts and Connecticut communities or

five optimally fluoridated Connecticut communities.

Among the subjects who grew up in nonfluoridated areas of Massachusetts and Connecticut, it was found that children who were reported to have begun brushing with fluoridated tooth- paste during the first two years of life and who reported they usually brushed more than once per day had an approximately three- to fourfold increase in the risk of enamel fluorosis, depend- ing on the specific enamel sur- faces affected.21 In this same population, children who were reported to have used a fluoride supplement throughout the sec- ond through eighth years of life had an approximately two- to eightfold increase in the risk of enamel fluorosis, again depend- ing on the specific enamel sur- faces affected.21

The subjects in the second population grew up in optimally fluoridated areas in Connecti- cut.25 These areas had begun fluoridation many years before these children were born, and when the water departments were contacted, they indicated that episodes of below-optimum fluoridation were rare and brief over the lifetimes of the sub- jects. In this population, it was found that children who were reported to have usually brushed with more than a pea- size amount of toothpaste and who were reported to have usu- ally brushed more than once per day had a six- to eightfold increase in the risk of enamel fluorosis, depending on the spe- cific surfaces affected.25

Children in these optimally fluoridated areas who inappro- priately were given fluoride supplements had an approxi- mately six- to 10-fold increase in the risk of enamel fluorosis,

again depending on the specific enamel surfaces affected.25 In this population, the reported use of infant formula in the form of a powdered concentrate produced an approximately four- to 10-fold increase in the risk of enamel fluorosis, once again depending on the specific surfaces affected.25

Two trained examiners measured enamel fluorosis using the Fluorosis Risk Index.40 For the attributable risk analyses presented in this article, I included a subject as a fluorosis case if he or she had mild-to-moderate enamel fluo- rosis as defined by Møller41 that was characterized by the pres- ence of paper-white streaking, coalescence of opacities or both on more than 50 percent of two or more enamel surface zones, anywhere throughout the denti- tion.41 A fluorosis control was defined as any subject who was fluorosis-free throughout the dentition.

Two examiners conducted random, blind inter- and intraexaminer reliability exami- nations daily throughout the data collection period. There were few cases (approximately 2 percent) of subjects showing signs of more severe fluorosis, which was characterized by the presence of brown staining or pitting. Therefore, I included these few subjects in the analy- ses with the rest of the cases.

I retrospectively obtained fluo- ride exposure history via a self- administered, closed-ended questionnaire that was mailed to the parents of all case and control subjects. Parents were offered $20 for return of the com- pleted questionnaire. This ques- tionnaire had been pretested and used in two fluorosis risk investi- gations.17,27 The subject’s name

748 JADA, Vol. 131, June 2000

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Copyright ©1998-2001 American Dental Association. All rights reserved.

was handwritten on the cover of the questionnaire and into each of the questions within the ques- tionnaire. This was done to help keep parents with several chil- dren mindful of the specific child we were asking about.

For each quarter of the first year of life—birth through 3 months, 4 through 6 months, and so on—parents were asked to indicate, by checking the appropriate box, whether the subject’s main source of food was breast milk, ready-to-feed infant formula, formula in the form of liquid concentrate, for- mula in the form of powdered concentrate, cow’s milk or solid food. They also were asked to do this for the second year of the children’s lives as a whole. Then they were asked to write in the usual brand of infant for- mula used, which allowed me to determine whether the formula was milk- or soy-based. For each of the first eight years, parents were asked to write in the city and state (country if not the United States) where the subject lived for each year. Also for each of the first eight years, parents were asked to indicate by checking the appro- priate box whether the subject was given plain vitamins with- out fluoride, a vitamin drop with fluoride, a vitamin tablet with fluoride, a fluoride drop alone, a fluoride tablet alone or nothing. Parents were asked to indicate by circling the best choice whether the subject usu- ally did not brush, usually brushed once a day or usually brushed more than once a day during the first eight years, and by circling the best drawing to indicate whether the subject usually placed a pea-sized amount or more of toothpaste on his or her toothbrush when

brushing during the first eight years. Parents were asked to indicate by circling the appro- priate age at which the subjects began to brush and at what ages they helped the subjects brush their teeth. For each of the first eight years, parents were asked to write in the sub- jects’ places of residence. Parents also were asked to indi- cate whether they used bottled water or a tap water filter for more than two of the first eight years. Finally, they were asked to indicate their relationship to the subjects and to indicate by circling the appropriate ages during which of the subjects’ first eight years they had lived with them.

I included for analysis only subjects whose questionnaires were completed by parents who had resided with the subjects for the entire eight-year survey period. I assessed questionnaire reliability by having a random- ly drawn sample of respondents complete a second question- naire that was mailed at least one month after the completion of the first.

I included in the nonfluori- dated group analysis only data from subjects born after 1979 who were residents of a non- fluoridated community for the entire eight-year survey period. For the optimally fluoridated group analysis, I included only data from subjects born after 1979 who were residents of an optimally fluoridated commu- nity for the entire eight-year survey period. I determined the fluoridation status of prior resi- dences other than in the survey communities using the Fluoridation Census.42

I derived adjusted attribut- able risk percent estimates and adjusted 95 percent confidence

intervals, or CIs, individually for early fluoride exposures found to be associated with an increased risk of mild-to- moderate enamel fluorosis, based on logistic regression analyses.43,44 I derived these attributable risk percent esti- mates separately for the nonflu- oridated study sample and for the optimally fluoridated study sample. I included variables found to have been either important predictors of enamel fluorosis or important covari- ates in the relative risk analy- ses21,25 in each of the attributa- ble risk analyses.

RESULTS

A total of 1,091 subjects (94 percent of those enrolled and 15 percent of those eligible to enroll) were examined for fluo- rosis in the nonfluoridated study sample. A total of 867 subjects (95 percent of those enrolled and 14 percent of those eligible to enroll) were examined for fluorosis in the optimally fluoridated study sample. Intra- and interexam- iner agreement on case vs. con- trol status was 98.9 percent and 93.8 percent, respectively (κ = 0.93 and 0.73, respective- ly), in the nonfluoridated sam- ple and 100 percent and 86 per- cent, respectively (κ = 1.0 and 0.70, respectively), in the opti- mally fluoridated sample. The prevalence of mild-to-moderate enamel fluorosis was 39 per- cent in the nonfluoridated sam- ple and 34 percent in the opti- mally fluoridated sample. Eighty-four percent of the cases from the nonfluoridated com- munities and 74 percent of cases from the optimally fluori- dated communities involved the maxillary anterior teeth.

The questionnaire return

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Copyright ©1998-2001 American Dental Association. All rights reserved.

rate was 90 percent in the non- fluoridated sample and 91 percent in the optimally fluori- dated sample. A 12 percent reliability sample in the nonflu- oridated sample and a 16 percent reliability sample in fluoridated revealed an average agreement between the second and first questionnaire respons- es of 87 percent for both study samples.

A total of 250 subjects with mild-to-moderate enamel fluo- rosis and 179 fluorosis-free con- trols were available in the non- fluoridated study sample for analysis, after exclusions based on year of birth, fluoridation history or completion of the questionnaire by someone other than parents who had lived with their children throughout the entire eight-year survey

period. These subjects ranged in age from 10 to 13 years of age (mean = 12.5 years), and 57 percent were girls. Eighty-six percent of these subjects were lifelong residents of their cur- rent communities.

A total of 180 subjects with mild-to-moderate fluorosis and 54 fluorosis-free control sub- jects were available in the fluoridated study sample for analysis, again after exclusions based on year of birth, fluorida- tion history or completion of the questionnaire by someone other than parents who had lived with their children throughout the entire eight-year survey period. These subjects ranged in age from 10 to 14 years of age (mean = 12.9 years), and 56 percent were girls.

Tables 1 and 2 show the mul-

tiple logistic-regression– derived, adjusted attributable risk percent estimates for these two study samples. Individual attributable risk percents do not add to 100 percent, since the variables studied in both samples were not mutually exclusive exposures.43

For the nonfluoridated study sample, Table 1 shows that an estimated 65 percent of the cases could be attributed to or explained by exposure to fluo- ride supplements during the second through eighth year of life. Thirty-four percent of the cases in this sample could be explained by a history of having begun to brush with toothpaste during the first two years and having usually brushed more than once per day. The logistic- regression–derived test for

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TABLE 1

29

65

34

8

6

45

* Estimate of cases attributable to each specific fluoride source based on logistic regression modeling.21 Note that individual attributable risk percents do not add up to 100 percent, as fluoride supplementation and toothbrushing history are not mutually exclusive exposures.43

† CI: Confidence interval. ‡ Reference group: no supplementation during each of the identified periods. § Reference group: began after year 2; brushed once per day.

FLUORIDATION SOURCE

Supplementation History‡

ATTRIBUTABLE RISK PERCENT ESTIMATES* ATTRIBUTABLE RISK 95 PERCENT CI†

ESTIMATED PERCENTAGE OF ENAMEL FLUOROSIS CASES ATTRIBUTABLE TO SPECIFIC FLUORIDE SOURCES IN A NONFLUORIDATED POPULATION.

Supplemented Year 1

Supplemented Years 2 Through 8

Toothbrushing History§

Began During Years 1 and 2; Brushed More Than Once per Day

Began During Years 1 and 2; Brushed Once per Day

Began After Year 2; Brushed More Than Once per Day

Used More Than a Pea-sized Amount of Toothpaste

−6-52

34-81

18-47

−2-17

−4-14

−7-72

Copyright ©1998-2001 American Dental Association. All rights reserved.

trend across the three tooth- brushing exposure categories was statistically significant, suggesting a dose response effect; however, the negative CI limits for two of the toothbrush- ing exposure categories indicate that the analysis cannot say with 95 percent certainty that cases could be attributed to these two exposure histories. While not statistically signifi- cant, the findings suggested that perhaps 45 percent of the observed cases could be attrib- uted to the usual early use of greater than a pea-sized amount of toothpaste when brushing.

For the study subjects who grew up in optimally fluoridat- ed communities, Table 2 shows that an estimated 13 percent of the cases could be explained by

the inappropriate use of fluo- ride supplements during the first two years of life. Forty-six percent of the cases could be explained by a history of having usually used more than a pea- sized amount of toothpaste when brushing and usually having brushed more than once per day. The test for trend across the three toothbrushing exposure categories was statis- tically significant, again sup- porting the presence of a dose- response effect. A clear associa- tion with age when brushing began was not observed in this study sample, when adjusted for usual toothbrushing fre- quency and amount of tooth- paste used.

Table 2 also shows that 9 percent of the cases could be explained by a history of having

used infant formula in the form of a powdered concentrate as the main source of food, espe- cially during the last quarter of the first year. There was no suggestion of an association with ready-to-feed infant for- mula and no significant associa- tion was observed with liquid concentrate formula. The reported use of either bottled water or a tap water filter was not statistically significantly associated with fluorosis in the analyses from either nonfluori- dated or optimally fluoridated populations.

DISCUSSION

Attributable risk percent esti- mates associated with enamel fluorosis are useful in assessing the public health impact of par- ticular fluoride exposures.

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6-20

25-61

8-35

−6-10

3-15

TABLE 2

13

46

22

2

9

* Estimate of cases attributable to each specific fluoride source based on logistic regression modeling.24 Note that individual attributable risk percents do not add up to 100 percent, as fluoride supplementation, toothbrushing history and infant formula use are not mutually exclusive exposures.43

† CI: Confidence interval. ‡ Reference group: no fluoride supplementation years 1 through 2. § Reference group: pea-sized amount of toothpaste, once per day. ** At 10 to 12 months of age. Referent group: no infant formula used.

FLUORIDATION SOURCE ATTRIBUTABLE RISK PERCENT ESTIMATE* ATTRIBUTABLE RISK 95 PERCENT CI†

ESTIMATED PERCENTAGE OF ENAMEL FLUOROSIS CASES ATTRIBUTABLE TO SPECIFIC FLUORIDE SOURCES IN AN OPTIMALLY FLUORIDATED POPULATION.

Supplemented Years 1 Through 2

Toothbrushing History§

More Than a Pea-sized Amount of Toothpaste, More Than Once per Day

More Than a Pea-sized Amount of Toothpaste, Once per Day

Pea-sized Amount of Toothpaste, More Than Once per Day

Formula as Powdered Concentrate**

Supplementation History‡

Copyright ©1998-2001 American Dental Association. All rights reserved.

Children in the United States today are exposed to a variety of fluoride sources during early childhood. Some sources, such as fluoride supplements, are intended to be ingested. Others, such as fluoride tooth- paste, are intended for topical use but are nevertheless ingested by preschool-aged chil- dren who typically have not begun to expectorate any or enough of the toothpaste with which they brush.45,46 It is important when estimating the attributable risk percent specif- ic to a particular fluoride expo- sure that this estimate be adjusted for the effects of the other exposures. In this way, the estimate of the effect of a particular exposure is not biased by the other exposures. It also is important to recognize that the effect of exposure to a specific fluoride source within a population is always in the con- text of exposure to that source along with exposure to the other fluoride sources within that population. In this way, the fluorosis impact of one fluo- ride source among several can be estimated, and appropriate professional and public health action can be taken.

In this study, approximately two-thirds of mild-to-moderate enamel fluorosis cases observed in optimally fluoridated areas and at least one-third of mild- to-moderate enamel fluorosis cases observed in nonfluoridat- ed areas could be attributed to or explained by habits related to the early use of fluoride toothpaste. Three potentially important behaviors associated with early toothbrushing are when toothbrushing began, the usual daily frequency of tooth- brushing and the usual amount of toothpaste used during

brushing. All three of these behaviors are indicators of the overall fluoride ingestion associ- ated with early toothbrushing.

In the nonfluoridated study population, the age at which toothbrushing began and the usual frequency of toothbrush- ing were most significantly associated with enamel fluoro- sis. While not statistically sig- nificant, these findings suggest that as much as 45 percent of the enamel fluorosis cases could be explained by a history of having usually used more than a pea-sized amount of tooth- paste when brushing.

In the optimally fluoridated study population, the usual amount of toothpaste used when brushing and the usual daily frequency of toothbrush- ing were most significantly associated with enamel fluoro- sis. The statistically significant trends observed with early toothpaste use in both study samples suggests a dose- response relationship.

A previous investigation of a Connecticut study population who grew up in optimally fluoridated communities esti- mated that approximately 70 percent of enamel fluorosis cases could be attributed to early toothbrushing behav- iors.34 Findings from Canadian and Australian studies of chil- dren who were current resi- dents of optimally fluoridated areas suggested that many of the enamel fluorosis cases seen in those investigations also could be attributed to early toothbrushing habits.12,15 This study’s findings from the opti- mally fluoridated study sample are consistent with those past reports. Importantly, this study’s findings from the non- fluoridated study sample sug-

gest that early toothpaste use behaviors may affect the prevalence of enamel fluorosis, regardless of whether the com- munity is optimally fluoridated.

These findings reinforce the important opportunity and need for dentists and hygienists to guide the parents of preschool- aged children in proper fluoride toothpaste use. Specifically, dental professionals should advise parents to supervise their preschool-aged children during toothbrushing and be sure that the children use only a small pea-sized amount of toothpastes when brushing. This advice should be given and followed regardless of whether the children live in an optimally fluoridated or nonfluoridated area. Parents should encourage their children to expectorate the toothpaste at the earliest possible age rather than swal- low it, avoid toothpastes with flavors that would encourage young children to wish to eat the toothpaste, and keep tooth- paste and all other fluoride- containing products out of the reach of preschool-aged chil- dren. These findings further support the call for a lower- fluoride-concentration tooth- paste, specifically for use by pre- school-aged children.34,47-49

The findings of this study indicate that nearly two-thirds of the cases of mild-to-moderate enamel fluorosis observed in nonfluoridated areas could be attributed to or explained by the early use of fluoride supple- ment. Subjects in this investi- gation would have been given fluoride supplements under the pre-1994 protocol; these find- ings strongly support the new, lower dosage fluoride supple- mentation protocol, which has been accepted by both the

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Copyright ©1998-2001 American Dental Association. All rights reserved.

American Dental Association and the American Academy of Pediatrics (Table 3).50,51

The ADA Guide to Dental Therapeutics50 is a good resource on the use of fluoride supplements, as well as other fluoride-containing compounds. Dentists and hygienists should evaluate the fluoride content of a child’s drinking water, while keeping in mind that the child may have access to more than one drinking water source dur- ing the day, both at home and in a child-care setting, for example. If the child’s drinking water is not from a municipal water supply of known fluoride concentration, the drinking water sources must be tested for their fluoride content. Then, a proper decision regarding what fluoride supplementation, if any, is appropriate can be made based on the protocol in Table 3. By doing this, dentists can avoid inappropriately pre- scribing fluoride supplements to children who already are drink- ing adequately fluoridated water. It also is important to determine whether children are receiving a fluoride supplement as part of a multiple vitamin prescribed by a physician.

Dentists should ask parents to bring to the office any vitamin preparations their children are taking so the vitamins can be evaluated directly. Dentists also should ask parents to inform them if the children’s drinking water sources change.

The use of bottled drinking water complicates the process, as bottled water’s fluoride con- tent can vary markedly, and manufacturers are not required to list the fluoride content.52 A one-time test of the fluoride content of bottled water may not be sufficient to prescribe a fluoride supplement, as a child’s family might change the brand of bottled water it drinks or the fluoride concentration could change.

My current findings indicate that 13 percent of the cases of mild-to-moderate enamel fluo- rosis observed in optimally fluoridated areas could be attributed to or explained by the inappropriate use of fluo- ride supplements during the first two years of children’s lives while they lived in these optimally fluoridated areas. This is not surprising. The use of fluoride supplements by chil- dren living in optimally fluori-

dated areas has never been recommended by any profes- sional organization, given the likelihood of causing an above-optimal ingestion of fluo- ride.50, 51,53-55 Fortunately, the percentage of cases attributa- ble to inappropriate fluoride supplementation was relatively low in this study population and was approximately one- half that reported in the only previously published report of the attributable risk associated with enamel fluorosis and inappropriate fluoride supple- mentation.34 Nevertheless, this finding illustrates the need for dentists and hygienists to serve as a source of guidance to parents as to the proper use of fluoride supplements.

The findings of this investi- gation suggest that nearly 10 percent of the enamel fluorosis cases in optimally fluoridated areas could be explained by having used infant formula in the form of a powdered concen- trate during the first year. I observed no suggestion of an association between enamel fluorosis and infant formula— in any form—in the nonfluori- dated population. These find- ings support the continued con-

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None

None

None

None

TABLE 3

None

None

0.25 mg/day

0.50 mg/day

None

0.25 milligrams per day‡

0.50 mg/day

1.00 mg/day

* Revised schedule accepted by the American Dental Association,50 the American Academy of Pediatric Dentistry and the American Academy of Pediatrics.

† ppm: Parts per million. ‡ 2.2 mg sodium fluoride contain 1 mg fluoride ion.

AGE

Less Than 0.3 ppm† 0.3 to 0.6 ppm More Than 0.6 ppm

FLUORIDE CONCENTRATION IN THE DRINKING WATER

REVISED FLUORIDE SUPPLEMENTATION SCHEDULE.*

Birth to 6 Months

6 Months to 3 Years

3 to 6 Years

6 to 16 Years

Copyright ©1998-2001 American Dental Association. All rights reserved.

cern that the use of powdered concentrate formula mixed with optimally fluoridated water still may have an impact on the prevalence of enamel flu- orosis in optimally fluoridated areas.55,56

To my knowledge, this is the first investigation reporting attributable risk percent esti- mates associated with infant formula use after the U.S. for- mula manufacturers’ voluntary decision in 1979 to reduce the fluoride in their products. Therefore, other studies will need to be conducted to confirm these findings. In the interim, however, it may be prudent to recommend to parents living in optimally fluoridated areas who are feeding formula to their infants, that they either use a ready-to-feed formula or pre- pare formula from concentrate using bottled water with a known low-fluoride concentra- tion. Care should be taken, however, to explain to the par- ent that drinking optimally fluoridated water by itself is not a risk factor for noticeable enamel fluorosis,6,7 and that drinking optimally fluoridated water has proven important caries preventive benefits.7

The questionnaire used in these investigations originally was judged to possess content validity (that is, adequacy of the questions to measure what the questionnaire is suppose to measure)57,58 by me, my col- leagues, nondental–trained pretesters and a National Institutes of Health scientific review panel. Throughout its use in five separate investigations of several thousand subjects, there have been few questions raised by respondents relative to the meaning of questions. Beyond this, questions in this question-

naire have shown considerable predictive validity57,58 as used in the specific investigation report- ed in this article, as well as in previous investigations in which it has been used. For example, as hypothesized in previous toothpaste ingestion studies,47

adjusted multivariate analyses have consistently shown specific early toothpaste-use variables to be associated with enamel fluo- rosis diagnosed by examiners blind to the children’s fluoride exposure histories. This supports the likelihood that the question- naire has measured what it intended to measure.

In this type of study (case- controlled), guessing on the part of questionnaire respon- dents always diminishes the observed association between fluoride exposure and fluorosis or hides it entirely.59 In con- trast, if responses were biased such that a history of exposure to one fluoride source really reflected a true exposure to a different fluoride source, then the potential for an observed spurious association would exist. In this situation, howev- er, adjustment for the true risk factor by use of a multivariate analyses would reveal a true lack of association between the spurious factor and fluorosis. Therefore, the use of fully adjusted, multivariate analyses in this investigation lends fur- ther support to the validity of observed associations.

CONCLUSIONS

The findings reported in this article suggest that early tooth- brushing habits have an impor- tant impact on the prevalence of mild-to-moderate enamel fluo- rosis in both nonfluoridated and optimally fluoridated areas. At least one-third of the fluorosis

cases in nonfluoridated areas and two-thirds of the cases in optimally fluoridated areas could be explained by specific patterns of early fluoride tooth- paste use.

Approximately two-thirds of mild-to-moderate enamel fluoro- sis cases in nonfluoridated areas could be explained by the use of fluoride supplements under the pre-1994 supplementation pro- tocol. Inappropriate use of fluo- ride supplements explained 13 percent of fluorosis cases in optimally fluoridated areas. An additional 9 percent of fluorosis cases in optimally fluoridated areas were explained by the use of infant formula in the form of a powdered concentrate. This relationship with infant formula use was not seen in nonfluori- dated areas.

These findings reinforce the important role that health pro- fessionals can have in reducing the prevalence of enamel fluoro- sis in U.S. children today and suggest that much of the clini- cally noticeable enamel fluoro- sis seen today could be prevent- ed by specific changes in early childhood behaviors. In particu- lar, providing the parent of a young child with appropriate advice regarding the early use of fluoride toothpaste and fluo- ride supplements may have a significant impact on the preva- lence of enamel fluorosis in both nonfluoridated and opti- mally fluoridated populations. �

Dr. Pendrys is an associate professor, Department of Behavioral Sciences and Community Health, School of Dental Medicine, University of Connecticut Health Center, 263 Farmington Ave., Farmington, Conn. 06030-3910. Address reprint requests to Dr. Pendrys.

This study was supported by National Institute of Dental and Craniofacial Research grants DE08939 and DE9400110592.

The author thanks Drs. Ralph V. Katz and

754 JADA, Vol. 131, June 2000

RESEARCH

Copyright ©1998-2001 American Dental Association. All rights reserved.

Douglas E. Morse, coexaminers in these inves- tigations, as well as Ms. Laura Byrne-Maraj for her assistance with data management.

1. Dean HT, McKay FS. Production of mot- tled enamel halted by a change in common water supply. Am J Public Health 1939; 29:590-6.

2. Fejerskov O, Larsen MJ, Richards A, Baelum V. Dental tissue effects of fluoride. Adv Dent Res 1994;8(1):15-31.

3. Rozier RG. Epidemiologic indices for measuring the clinical manifestations of den- tal fluorosis: overview and critique. Adv Dent Res 1994;8(1):39-55.

4. Pendrys DG, Stamm JW. Relationship of total fluoride intake to beneficial effects and enamel fluorosis. J Dent Res 1990;69:529-38.

5. Clark DC. Trends in prevalence of dental fluorosis in North America. Community Dent Oral Epidemiol 1994;22:148-52.

6. Dean HT. The investigation of physiologi- cal effects by the epidemiologic method. In: Moulton FR, ed. Fluorine and dental health. Washington: American Association for the Advancement of Science; 1942:23-31. Publication 19.

7. Dean HT. Fluorine in the control of den- tal caries. Int Dent J 1954;4:311-77.

8. Newbrun E. Effectiveness of water fluori- dation. J Public Health Dent 1989;49:(5 spe- cial number):279-89.

9. Marthaler T. Clinical cariostatis effects of various methods and programs. In: Ekstrand J, Fejerskov O, Silverstone LM, eds. Fluoride in dentistry. Copenhagen: Munksgaard; 1988:252-75.

10. Murray JJ, Rugg-Gunn AJ, Jenkins GN. Fluoride toothpastes and dental caries. In: Fluoride in caries prevention. 3rd ed. Oxford, Mass.: Butterworth-Heinemann; 1991:127-60.

11. Riordan PJ. Fluoride supplements in caries prevention: a literature review and proposal for a new dosage schedule. J Public Health Dent 1993;53:174-89.

12. Osuji OO, Leake JL, Chipman ML, Nikiforuk G, Locker D, Levine N. Risk factors for dental fluorosis in a fluoridated communi- ty. J Dent Res 1988;67:1488-92.

13. Evans DJ. A study of developmental defects in enamel in 10-year-old high social class children residing in a non-fluoridated area. Community Dent Health 1991;8(1):31-8.

14. Milsom K, Mitropoulos CM. Enamel defects in 8-year-old children in fluoridated and non-fluoridated parts of Chesire. Caries Res 1990;24:286-9.

15. Riordan PJ. Dental fluorosis, dental caries and fluoride exposure among 7-year- olds. Caries Res 1993;27(1):71-7.

16. Holt RD, Morris CE, Winter GB, Downer MC. Enamel opacities and dental caries in children who used a low fluoride toothpaste between 2 and 5 years of age. Int Dent J 1994;44:331-41.

17. Pendrys DG, Katz RV, Morse DE. Risk factors for enamel fluorosis in a fluoridated population. Am J Epidemiol 1994;140:461-71.

18. Skotowski M, Hunt R, Levy S. Risk fac- tors for dental fluorosis in pediatric dental patients. J Public Health Dent 1995;55:154-9.

19. Ellwood R, O’Mullane D. Dental enamel opacities in three groups with varying levels of fluoride in their drinking water. Caries Res 1995;29:137-42.

20. Lalumandier J, Rozier R. The preva- lence and risk factors of fluorosis among patients in a pediatric dental practice. Pediatr Dent 1995;17:19-25.

21. Pendrys DG, Katz RV, Morse DE. Risk factors for enamel fluorosis in a nonfluoridated population. Am J Epidemiol 1996;143:808-15.

22. Rock W, Sabieha A. The relationship between reported toothpaste usage in infancy and fluorosis of permanent incisors. Br Dent J 1997;183:165-70.

23. Wang N, Gropen AM, Ogaard B. Risk factors associated with fluorosis in a non- fluoridated population in Norway. Community Dent Oral Epidemiol 1997;25:396-401.

24. Mascarenhas AK, Burt BA. Fluorosis risk from early exposure to fluoride tooth- paste. Community Dent Oral Epidemiol 1998;26:241-8.

25. Pendrys DG, Katz RV. Risk factors for enamel fluorosis in optimally fluoridated children born after the U.S. manufacturers’ decision to reduce the fluoride concentration of infant formula. J Am Epidemiol 1998; 148:967-74.

26. Holm A-K, Andersson R. Enamel miner- alization disturbances in 12-year-old children with known early exposure to fluorides. Community Dent Oral Epidemiol 1982;10: 335-9.

27. Pendrys DG, Katz RV. Risk of enamel fluorosis associated with fluoride supplemen- tation, infant formula, and fluoride dentifrice use. Am J Epidemiol 1989;130:1199-208.

28. Kumar JV, Green EL, Wallace W, Carnahan T. Trends in dental fluorosis and dental caries prevalences in Newburgh and Kingston, N.Y. Am J Public Health 1989; 79(5):565-9.

29. Woolfolk MW, Faja BW, Bagramian RA. Relation of sources of systemic fluoride to prevalence of dental fluorosis. J Public Health Dent 1989;49(2):78-82.

30. Bohaty BS, Parker WA, Seale NS, Zimmermann ER. Prevalence of fluorosis-like lesions associated with topical and systemic fluoride usage in an area of optimal water fluoridation. Pediatr Dent 1989;11:125-8.

31. Ismail AI, Brodeur JM, Kavanagh M, Boisclair G, Tessier C, Picotte L. Prevalence of dental caries and fluorosis in students, 11- 17 years of age, in fluoridated and non-fluori- dated cities in Quebec. Caries Res 1990;24(4): 290-7.

32. Riordan PJ, Banks JA. Dental fluorosis and fluoride exposure in Western Australia. J Dent Res 1991;70:1022-8.

33. Forsman B. Early supply of fluoride and enamel fluorosis. Scand J Dent Res 1977; 85(1):22-30.

34. Pendrys DG. Risk of fluorosis in a fluo- ridated population. JADA 1995;126:1617-24.

35. Coughlin SS, Benichou J, Weed DL. Attributable risk estimation in case-control studies. Epidemiol Rev 1994;16(1):51-64.

36. Driscoll WS, Horowitz HS. A discussion of optimal dosage for dietary fluoride supple- mentation. JADA 1978;96:1050-3.

37. American Academy of Pediatrics Committee on Nutrition. Fluoride supplemen- tation: revised dosage schedule. Pediatrics 1979;63:150-2.

38. Feigal RJ. Recent modifications in the use of fluorides by children. Northwest Dent 1983;62(5):19-21.

39. Johnson J Jr, Bawden JW. The fluoride

content of infant formulas available in 1985. Pediatr Dent 1987;9(1):33-7.

40. Pendrys DG. The Fluorosis Risk Index: a method for investigating risk factors. J Public Health Dent 1990;50:291-8.

41. Møller IJ. Clinical standards used for diagnosing fluorosis. In: McClure FJ, ed. Water fluoridation. Bethesda, Md.: U.S. Department of Health, Education, and Welfare; 1970:72.

42. Fluoridation census 1992. Atlanta, Ga.: U.S. Department of Health and Human Services; 1992.

43. Bruzzi P, Green SB, Byar DP, Brinton LA, Schairer C. Estimating the population attributable risk for multiple risk factors using case-control data. Am J Epidemiol 1985;122:904-14.

44. Greenland S. Applications of stratified analysis methods. In: Rothman KJ, Greenland S, eds. Modern epidemiology. 2nd ed. Philadelphia: Lippincott-Raven; 1997:295-7.

45. Barnhart WE, Hiller LK, Leonard GJ, Michaels SE. Dentifrice usage and ingestion among four age groups. J Dent Res 1974;53:1317-22.

46. Dowell TB. The use of toothpaste in infancy. Br Dent J 1981;150:247-9.

47. Beltran ED, Szpunar SM. Fluoride in toothpastes for children: suggestion for change. Pediatr Dent 1988;10:185-8.

48. Horowitz HS. The need for toothpaste with lower than conventional fluoride concen- trations for preschool-aged children. J Public Health Dent 1992;52:216-21.

49. Burt BA. Changing patterns of systemic fluoride intake. J Dent Res 1992;71:1228-37.

50. Burrell KH. Systemic and topical fluo- rides. In: Ciancio S., ed. ADA guide to dental therapeutics. Chicago: ADA Publishing Co. Inc.; 1998:214-25.

51. Committee on Nutrition, American Academy of Pediatrics. Fluoride supplemen- tation for children: interim policy recommen- dations. Pediatrics 1995;95:777.

52. Levy SM, Kiritsy MC, Warren JJ. Sources of fluoride intake in children. J Public Health Dent 1995;55(1):39-52.

53. American Dental Association Council on Dental Therapeutics. Accepted dental re- medies. 32nd ed. Chicago: American Dental Association; 1967:395-420.

54. American Academy of Pediatrics Committee on Nutrition. Fluoride as a nutri- ent. Pediatrics 1972;49:456-60.

55. American Academy of Pediatrics Committee on Nutrition. Fluoride supplemen- tation: revised dosage schedule. Pediatrics 1979;63:150-2.

56. Van Winkle S, Levy S, Kiritsky M, Heilman J, Wefel J, Marshall T. Water and formula fluoride concentrations: significance for infants fed formula. Pediatr Dent 1995;17:305-10.

57. McDowell I, Newell C. Measuring health: A guide to rating scales and question- naires. New York: Oxford University Press; 1987:27-9.

58. Aday L. Designing and conducting health surveys. San Francisco: Jossey-Bass Publishers; 1989:47-50.

59. Rothman KJ, Greenland S. Precision and validity in epidemiologic studies. In: Rothman KJ, Greenland S, eds. Modern epi- demiology. Philadelphia: Lippincott-Raven; 1997:127-32.

JADA, Vol. 131, June 2000 755

RESEARCH

Copyright ©1998-2001 American Dental Association. All rights reserved.

  • RISK OF ENAMEL FLUOROSIS IN NONFLUORIDATEDAND OPTIMALLY FLUORIDATED POPULATIONS: CONSIDERATIONS FOR THE DENTAL PROFESSIONAL
    • MATERIALS AND METHODS
    • RESULTS
    • DISCUSSION
    • CONCLUSIONS

FluorideSupplemen

tation.docx

FLUORIDE SUPPLEMENT PROGRAM

GUIDELINES

1. The program is primarily for pre-school children (6 months–6 years), but may be provided up to age 16 (targeting children who do not attend a school with fluoridated water), who are not presently receiving fluoridated drinking water, other fluoride supplements, or vitamins with fluoride.

2. Whether or not a child is receiving fluoride can be determined by the answers to questions on the questionnaire and consent form (OH-9). A copy of the form is included in this section.

3. When bottled water is being used as the primary source of drinking water, the fluoride content of the water should be determined. If the child’s legal representative is unaware of the fluoride content of the bottled water, there are several sources of information, which can be helpful in learning the fluoride content of different brands of bottled water. Generally, bottled water has a toll-free phone number printed on the label, or a product web site, which can be accessed to learn the fluoride content of the bottled water. Additional sources for learning the fluoride content of bottled water can be found at International Bottled Water Association (IBWA) Information Hotline: 1-800-WATER-11 or the International Bottled Water Association Website http://www.bottledwater.org/default.htmDo not submit a sample of bottled water for testing, without first attempting to determine the fluoride content of the bottled water.

4. If the child is not receiving fluoride in the water supply, an analysis of the natural fluoride content of the home water supply must be performed prior to prescribing fluoride supplementation. Instructions for taking and submitting a water sample are provided on the reverse side of “Information for Parents or Guardians”.

5. The maximum amount of fluoride a child under six should receive is 0.5 mg. fluoride ion per day.

6. Fluoride drops (8 drops–1 mg. fluoride ion) are packaged in plastic bottles containing one ounce liquid with about 500 drops (62.5 mg. fluoride ion) per bottle.

7. Fluoride chewable tablets (0.5 mg. fluoride ion) are packaged in plastic bottles containing 120 tablets (60 mg. fluoride ion) per bottle.

8. Dosage levels of fluoride drops or tablets depend on the age of the child and the amount of fluoride in the drinking water (from fluoride water sample tests). The dosage schedule for fluoride drops or tablets is included in the fluoride supplement protocols. For patients with abnormal fluoride test results of water samples submitted to the State Lab, issuing of fluoride supplements (drops or tablets) and follow-up should be followed per protocol.

9. If the test results from the water sample are:

· Equal to or greater than 2.00 ppm fluoride concentration, submit another sample of the water source to the State Lab for confirmation testing.

· If both water samples are equal to or greater than 2.00 ppm up to 4.00 ppm fluoride concentration, recommend to the parent or guardian that children equal to or less than 8 years of age should consume another source of water.

· Equal to or greater than 4.00 ppm fluoride concentration, recommend that both children and adults should consume another source of water.

· The Environmental Protection Agency classifies water with equal to or greater than 2.00 ppm fluoride concentration as the Secondary Containment Level and water with equal to or greater than 4.00 ppm fluoride concentration as the Maximum Containment Level for fluoride in water.

· When both water samples are equal to or greater than 4.00 ppm fluoride concentration, the nurse working with the Fluoride Supplement Program in the local health department should contact the local health department environmentalists and request an investigation of the water source.

· If the second water samples, comes back less than 2.00 ppm, submit a third water sample to the State Lab for testing.

· If fluoride concentration in two of the three samples is less than 2.00 ppm, follow the Fluoride Supplements Protocols for water samples with fluoride concentrations less than 2.00 ppm. If the fluoride concentration in two of the three samples is equal to or greater than 2.00 ppm, follow Fluoride Supplement Protocols for water samples with fluoride concentrations equal to or greater than 2.00 ppm.

· For further clarifications and directions, call the Oral Health Program at 502-564-3246, extension 4421.

10. Orders for fluoride supplement drops or tablets must be signed by the health officer, another physician, a dentist, or another health professional with prescriptive authority. Protocols may be used—one copy will cover all children in the program. A sample copy is included in this section. If prescription blanks are used, a signed prescription for fluoride must be in each child’s folder.

11. Parents or guardians must be advised concerning the importance of giving their child no more than the prescribed amounts of fluoride. It should be called to the attention of the parent or guardian that excessive amounts (i.e., more than 2 mg. per day) over an extended period of time (two or three months) may cause tooth discoloration during their development; with white spots appearing on the child’s permanent teeth. In addition, they need to be told of the potentially toxic nature of fluoride when ingested in large doses at a single time.

If, for example, a 22 pound child takes 264 mg. of sodium fluoride

(120 mg. fluoride ion) at any single time, symptoms of acute toxicity

can occur (stomach upset, vomiting). The minimum lethal dose for a

22-pound child is 480 mg. of sodium fluoride.

12. If it is determined that a child will participate in a preventive dental program, a questionnaire and consent form, the fluoride analysis of home water supply report, and a record of the amount of fluoride to be provided, if needed, shall be made a part of the child’s permanent health record. (Each participating child in the family must have a signed questionnaire and consent form and a record of the amount of fluoride to be taken.)

13. If more than one child in a family is to receive the fluoride supplement, written instructions for each child must be given to the parent.

14. A 3-month supply of supplements may be provided for each child in a family. Empty containers should be returned before providing a replacement. At this time, a determination should be made whether circumstances affecting the amount of fluoride supplement to be provided have changed, such as change in address, change in water source or the ‘aging out’ of the impacted children.

Questions to Ask Parents

a. Have you moved?

b. Have you changed your water supply? (Hint: even redrilling a well may impact the fluoride intake of the family.)

c. Has the child been placed on a vitamin supplement with fluoride?

Fluoride Supplementation Recommendations are based on the current guidelines of the American Dental Association, http://www.ada.org/2684.aspx#dosschedule

For additional information, please call the Oral Health Administrator at 502-564-3246, ext 4421.

Water Samples Tested for Fluoride Concentration

Results of Initial Water Sample Test

Fluoride Concentration

Equal to or greater than 2.00 ppm

Submit another sample of the water source to the State Lab for testing

Less than 2.00 ppm

Follow Fluoride Supplement Protocols

Less than 2.00 ppm

Submit another sample of the water source to the State Lab for testing

Equal to or greater than 4.00 ppm

Recommend children and adults consume another source of water

RN/RDH responsible for Fluoride Supplement Program at LHD should contact LHD environmentalist and request an investigation of the water source

Equal or greater than 2.00 ppm to 4.00 ppm

Recommend children 8 years of age and younger consume another source of water

2 water samples equal to or greater than 2.00 ppm

Follow chart for readings equal to or greater than 2.00 ppm

2 water samples less than 2.00 ppm

Follow Fluoride Supplement Protocols

For further information or directions, contact

the Oral Health Program

502-564-3246 x 4421

FLUORIDE SUPPLEMENT PROTOCOL

Infants and preschool children who are not drinking fluoridated water or who are not taking vitamins with fluoride should be given this essential nutrient. A laboratory test done on a sample of the drinking water supply will tell how much fluoride is in the water and the amount of the supplement that may be needed.

Call the Oral Health Program at 502-564-3246 to order forms, fluoride supplements, water sample, and collection kits or if further information is needed.

HEALTH RISK OR CONDITION TREATMENT/ INTERVENTION EDUCATION/ COUNSELING FOLLOW-UP
Unfluoridated drinking water source may be:

· Well

· Cistern

· Bottled

· Spring

Distribute one (1) bottle of fluoride drops and/or one (1) bottle of fluoride tablets to each child with individualized doses as follows: NaFrinse Drops – 1 bottle has about 500 drops fluoride.

NaFrinse Tablets – 1 bottle contains 120 tablets.

Children under 3 are not issued tablets. Dosage depends on age of child and amount of fluoride in drinking water.

At each preventive visit ask:

1. Have you moved?

2. Has the source of your child’s drinking water changed?

3. Is child taking vitamin with fluoride supplement?

Yes response to #1 and 2—assess new water supply, if indicated

Yes response to #3—discontinue fluoride supplement

DOSAGE

Age of child Fluoride in water

0 to 0.3 ppm

Fluoride in water

0.3 to 0.6 ppm

Fluoride in water

0.6 ppm and above

Age birth – 6 months None None None
Age 6 months – 3 yrs 2 drops – .25 mg 1 time per day

(8 month supply)

None None
Age 3 – 6 yrs 4 drops – .50 mg 1 time per day

(4 month supply)

or

1 tablet – .50 mg 1 time per day

(About a 4 month supply)

2 drops – .25 mg 1 time per day

(8 month supply)

Must give drops. There are no .25 mg tablets.

None
Age 6 – 16 yrs *

*Children who do not attend school with a fluoridated water supply may continue in the program.

8 drops – 1.0 mg 1 time per day

(2 month supply)

or

2 tablets – .50 mg 1 time per day (2 month supply)

4 drops – .50 mg 1 time per day

(4 month supply)

or

1 tablet – .50 mg 1 time per day

(4 month supply)

None
Dispose of unused drops or tablets by:

· Returning any unused liquid or tablets to LHD

· Flushing unused liquid or tablet down toilet

· Placing unused liquid or tablets in disposable trash container

Source: American Dental Association’s Council on Scientific Affairs: Fluoride Supplement Dosage Schedule: 2010

__________________________________________________________

Physician, Dentist, Other Date

PIIS00028177146282

69.pdf

C O M M E N T A R Y G U E S T E D I T O R I A L

628 JADA, Vol. 140 http://jada.ada.org June 2009

Editorials represent the opinions of the authors and not those of the American Dental Association.

Fluoridated toothpaste and the prevention of early childhood caries A failure to meet the needs of our young

I n the United States, dental caries is on the rise in children, es- pecially among the very young and the poor.1 The cause is not fully understood but likely is related to the consumption of in- creasingly available, inexpensive foods containing excess sug- ars, as well as to the now-ubiquitous habit of snacking and

drinking sweetened drinks throughout the day.2,3

Dental services for low-income children in the United States, cov- ered through the Early Periodic Screening, Diagnosis and Treatment (EPSDT) Program—Medicaid’s child health insurance program— have achieved limited success in reducing dental caries. Access to dentists accepting Medicaid payment remains a major obstacle for these children.4 As a consequence, in some states, public health offi- cials have encouraged medical care providers to screen children from birth to 24 months of age for dental care needs and to apply sodium fluoride varnish during primary care visits.5 Researchers are investi- gating other strategies, such as combining povidone-iodine and fluo- ride varnish or xylitol syrups and confections.6,7

A more accessible and less costly strategy to prevent caries among young children is the regular use of fluoridated toothpaste. Con- cerned about the rising rates of early childhood caries (ECC), an ex- pert panel convened in 2007 by the U.S. government recommended that children younger than 2 years who are at high risk of experienc- ing caries brush twice per day with a “smear” of regular U.S. fluo- ride toothpaste (typically containing about 1,100 parts per million fluoride) and that children aged 2 to 6 years brush twice daily with no more than a pea-sized amount of U.S. fluoridated toothpaste.8

Regular toothpaste typically contains about 1,100 parts per million fluoride.

However, there is resistance among dentists, physicians and par- ents in the United States to using regular fluoridated toothpaste with very young children; the U.S. Food and Drug Administration (FDA) Drug Facts label discourages its use in this population. Fluoridated toothpaste is packaged with the mandatory warning: “Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or con-

It is time for the dental profession, the dental

industry and the government to

reconsider instructions to parents regarding

the use of fluoridated toothpaste for children

younger than 2 years.

Peter M. Milgrom, DDS; Colleen E. Huebner, PhD, MPH; Kiet A. Ly, MD, MPH

GUEST EDITORIAL

Copyright © 2009 American Dental Association. All rights reserved. Reprinted by permission.

tact a Poison Control Center right away.”9

The intention behind the choice of the terms “smear” and “pea-sized” in the expert report was to limit children’s excess exposure to fluoride. However, without evidence of the benefits and risks associated with fluo- ride use, the expert panel rec- ommendation will have little impact, particularly while the FDA limits the directions for use to “adults and children 2 years of age and older.”9

The concentration of fluoride in toothpaste varies from coun- try to country in accord with government regulations, which makes it difficult to compare study results. The FDA allows dentifrices containing 850 to 1,150 ppm total fluoride for use by children 2 years and older and 1,500 ppm fluoride for use by those 6 years and older. However, consumers and health care providers often do not un- derstand the distinction. The la- beling is confusing because of the different forms of fluoride used and the use of percent weight/volume measures; un- derstanding these technical terms requires health literacy beyond that of many Americans.

It is time for the dental pro- fession, the dental industry and the government to reconsider instructions to parents regard- ing the use of fluoridated tooth- paste for children younger than 2 years. Unfortunately, the lit- erature concerning toothpaste use in the very young is scant. Fluoridated toothpaste is highly effective in preventing caries in children’s permanent denti- tion,10 but only one study has demonstrated its efficacy in doing so in the primary denti- tion of very young children. Described by its authors as an

effectiveness study of a program for parents with low incomes, not a trial of toothpaste’s effica- cy, it nonetheless provided a comparison of the use of fluori- dated toothpaste—either 440 ppm (monosodium fluoride 0.304 percent weight/volume) or 1,450 ppm (sodium fluoride 0.32 percent weight/volume)—with no use of fluoridated tooth- paste.11 The investigators as- signed families to receive tooth- paste and educational materials regularly by mail while their children were aged 1 to 51/2

years. Clinical examinations conducted when the children were 5 to 6 years old found an advantage for children in the 1,450-ppm fluoride group rela- tive to those in the 440-ppm group and to those in the un- treated control group. Overall, they found that the 440-ppm fluoride intervention had no ad- vantage relative to the control. In a study of 1,100-ppm fluoride toothpaste used by preschool children in China, You and col- leagues12 reported equivocal findings. This latter study does not meet FDA scientific stand- ards for a randomized clinical trial of a regulated drug, but its results suggest that further in- vestigation of fluoridated tooth- paste in very young children is warranted.

The benefit identified by Davies and colleagues11 of use of the 1,450-ppm toothpaste was not without associated risk. A follow-up study found that those who received the 1,450-ppm flu- oride toothpaste had significant- ly more fluorosis—some with fluorosis scores in the range con- sidered esthetically objection- able according to standardized measures used in public health—than did those who re- ceived the 440-ppm fluoride

toothpaste.13 Scores observed in the objectionable range were among children who lived in rel- atively less deprived communi- ties, suggesting an association between better adherence to home hygiene goals (that is, brushing begun at an early age) and greater risk of developing fluorosis. Data from Bentley and colleagues14 suggested the same.

Instructing parents to use a smear or a pea-sized amount of fluoride toothpaste with their young children is not universal- ly effective in reducing the amount applied to the tooth- brush. Also, it may be possible to apply too little toothpaste. Itthagarun and colleagues15 con- cluded, “Reduction of the amount of fluoride toothpaste to less than a pea-size in order to minimize the risk of fluorosis should be undertaken with cau- tion because it may compromise the cariostatic effects of the toothpaste, as shown by in vitro studies.” Other researchers had reached a similar conclusion in an earlier study involving sali- vary fluoride analyses.16 Thus, the amounts of U.S. 1,100-ppm fluoride toothpaste being recom- mended for use by our youngest children may be ineffective.

In the United States, in con- trast to some other countries (such as England and Australia), no fluoridated tooth- paste has been formulated for use by infants and toddlers, and none has been tested.10,17

Furthermore, using no tooth- paste or using only nonfluori- dated toothpaste (such as Baby Orajel Tooth and Gum Cleanser [Church and Dwight, Princeton, N.J.]) is regarded as the stand- ard of care for children of this age. There is nothing in the portfolio of research supported by the National Institute of

C O M M E N T A R Y G U E S T E D I T O R I A L

630 JADA, Vol. 140 http://jada.ada.org June 2009

Copyright © 2009 American Dental Association. All rights reserved. Reprinted by permission.

Dental and Craniofacial Research or sponsored by the Centers for Disease Control and Prevention on this topic; we do not know what investigations, if any, manufacturers are sponsoring.

Formally testing the benefits and secondary effects of the use of 1,100-ppm fluoridated tooth- paste with infants and toddlers in the United States who are at high risk of developing caries— and changing instructions for use on toothpaste labels, if ap- propriate—can benefit many children at little cost relative to current investments in dental research and profits from oral care products. Parents and pro- fessionals in poor and minority communities in the United States have told us in the course of our research that they would support a randomized placebo-controlled study of a special fluoridated toothpaste for infants and toddlers. Thus, we conclude on the basis of ex- isting science and the rising lev- els of dental caries that clinical trials of fluoridated toothpaste for very young children in the United States are overdue. ■

Dr. Milgrom is a professor, Department of Dental Public Health Sciences, and director, Northwest Center to Reduce Oral Health Disparities, University of Washington, Box 357475, Seattle, Wash. 98195-7475, e-mail

“dfrc@u.washington.edu”. Address reprint re- quests to Dr. Milgrom.

Dr. Huebner is an associate professor, Department of Health Services, University of Washington, Seattle, and the director, gradu- ate program in Maternal and Child Health Public Health Leadership, University of Washington, Seattle.

Dr. Ly is an acting assistant professor, Department of Dental Public Health Sciences, University of Washington, Seattle.

Disclosure. None of the authors reported any disclosures.

The development of this article was sup- ported in part by grant U54DE019346 from the National Institute of Dental and Craniofacial Research, National Institutes of Health, Bethesda, Md.

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2. Ismail AI, Lim S, Sohn W, Willem JM. Determinants of early childhood caries in low- income African American young children. Pediatr Dent 2008;30(4):289-296.

3. Thitasomakul S, Piwat S, Thearmontree A, Chankanka O, Pithpornchaiyakul W, Madyusoh S. Risks for early childhood caries analyzed by negative binomial models. J Dent Res 2009;88(2):137-141.

4. Milgrom P, Weinstein P, Huebner C, Graves J, Tut O. Empowering Head Start to improve access to good oral health for chil- dren from low income families (published on- line ahead of print Feb. 2, 2008). Matern Child Health J.

5. dela Cruz GG, Rozier RG, Slade G. Dental screening and referral of young chil- dren by pediatric primary care providers. Pediatrics 2004;114(5):e642-e652.

6. Berkowitz RJ, Koo H, McDermott MP, et al. Adjunctive chemotherapeutic suppression of mutans streptococci in the setting of severe early childhood caries: an exploratory study. J Public Health Dent (in press).

7. Milgrom P, Ly KA, Tut OK, et al. Xylitol pediatric topical oral syrup to prevent dental caries: a double blind, randomized clinical

trial of efficacy. Arch Pediatr Adolesc Med (in press). 8. Health Resources and Services Administration, Maternal and Child Health Bureau. Appendix A: Decision support ma- trix—topical fluoride recommendations. In: Topical Fluoride Recommendations for High- Risk Children: Development of Decision Support Matrix, Recommendations from Maternal and Child Health Bureau Expert Panel. Washington: Altarum Institute; 2009. “mohealthysmiles.typepad.com/ Topical%20fl%20recommendations%20for%20 hi%20risk%20children.pdf”. Accessed April 16, 2009.

9. Anticaries drug products for over-the- counter human use, 21 CFR 355;2006.

10. Marinho VC, Higgins JP, Sheiham A, Logan S. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2003;(1): CD002278.

11. Davies GM, Worthington HV, Ellwood RP, et al. A randomised controlled trial of the effectiveness of providing free fluoride tooth- paste from the age of 12 months on reducing caries in 5-6 year old children. Community Dent Health 2002;19(3):131-136.

12. You BJ, Jian WW, Sheng RW, et al. Caries prevention in Chinese children with sodium fluoride dentifrice delivered through a kindergarten-based oral health program in China. J Clin Dent 2002;13(4):179-184.

13. Tavener JA, Davies GM, Davies RM, Ellwood RP. The prevalence and severity of fluorosis in children who received toothpaste containing either 440 or 1,450 ppm F from the age of 12 months in deprived and less de- prived communities. Caries Res 2006; 40(1):66-72.

14. Bentley EM, Ellwood R, Davies RM. Fluoride ingestion from toothpaste by young children. Br Dent J 1999;186(9):460-462.

15. Itthagarun A, King NM, Rana R. Effects of child formula dentifrices on artificial caries like lesions using in vitro pH-cycling: prelimi- nary results. Int Dent J 2007;57(5):307-313.

16. DenBesten P, Ko HS. Fluoride levels in whole saliva of preschool children after brush- ing with 0.25 g (pea-sized) as compared to 1.0 g (full-brush) of a fluoride dentifrice. Pediatr Dent 1996;18(4):277-280.

17. Twetman S, Axelsson S, Dahlgren H, et al. Caries-preventive effect of fluoride tooth- paste: a systematic review. Acta Odontol Scand 2003;61(6):347-355.

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  • Fluoridated toothpaste and the prevention of early childhood caries: A failure to meet the needs of our young
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