Appendix 1 Excluded systematic reviews

Transcription

1 Appendix 1 Excluded systematic reviews For each identified systematic review and clinical study, the expert panel (see main article) determined final exclusion of publications. They excluded publications on the basis of the following criteria: they did not directly address one of the identified clinical questions; the panelists had concerns about the methodology described. EXCLUDED ARTICLE Garrison and Colleagues 1 Australian Research Centre for Population Oral Health 2 Niederman and Richards 3 Adair 4 American Academy of Pediatric Dentistry Liaison with Other Groups Committee; American Academy of Pediatric Dentistry Council on Clinical Affairs 5 American Academy of Pediatric Dentistry 6 Axelsson and Colleagues 7 Ten Cate 8 Rayner and Colleagues 9 Davies 10 Scheifele and Colleagues 11 Bader and Colleagues 12 National Institutes of Health 13 Clarkson and McLoughlin 14 Bårdsen 15 Limeback and Colleagues 16 RATIONALE FOR EXCLUSION Does not address the clinical questions Does not address clinical questions Does not address the clinical questions Does not address the clinical questions Does not address the clinical questions Does not address the clinical questions 1

2 Nainar 17 Fluoride supplement dosage. British Dental Association, the British Society of Paediatric Dentistry and the British Association for the Study of Community Dentistry 18 Gillcrist 19 Fluoride supplementation for children: interim policy recommendations. American Academy of Pediatrics Committee on Nutrition 201 Ismail 21 Clark Garrison GM, Loven B, Kittinger-Aisenberg LG. Clinical inquiries. Can infants/toddlers get enough fluoride through brushing? J Fam Pract. 2007;56(9):752, Australian Research Centre for Population Oral Health. The use of fluorides in Australia: guidelines. Aust Dent J Jun;51(2): Niederman R, Richards D. Evidence-based dentistry: concepts and implementation. J Am Coll Dent 2005;72(4): Adair SM. Evidence-based use of fluoride in contemporary pediatric dental practice. Pediatr Dent 2006;28(2): American Academy of Pediatric Dentistry Liaison with Other Groups Committee; American Academy of Pediatric Dentistry Council on Clinical Affairs. Guideline on fluoride therapy. Pediatr Dent ;30(7 suppl): American Academy of Pediatric Dentistry. Clinical guideline on fluoride therapy. Pediatr Dent 2004;26(7 suppl): Axelsson S, Söder B, Nordenram G, et al. *Effect of combined caries-preventive methods: a systematic review of controlled clinical trials. Acta Odontol Scand 2004;62(3): Ten Cate JM. Fluorides in caries prevention and control: empiricism or science. Caries Res 2004;38(3): Rayner J, Holt R, Blinkhorn F, Duncan K; British Society of Paediatric Dentistry. British Society of Paediatric Dentistry: a policy document on oral health care in preschool children. Int J Paediatr Dent 2003;13(4): Davies RM. The prevention of dental caries and periodontal disease from the cradle to the grave: what is the best available evidence? Dent Update 2003;30(4): , Scheifele E, Studen-Pavlovich D, Markovic N. Practitioner's guide to fluoride. Dent Clin North Am 2002;46(4): , xi. 12. Bader JD, Shugars DA, Bonito AJ. A systematic review of selected caries prevention and management methods. Community Dent Oral Epidemiol 2001;29(6):

3 13. National Institutes of Health (U.S.). Diagnosis and management of dental caries throughout life. NIH Consensus Statement 2001;18(1): Clarkson JJ, McLoughlin J. Role of fluoride in oral health promotion. Int Dent J 2000;50(3): Bårdsen A. "Risk periods" associated with the development of dental fluorosis in maxillary permanent central incisors: a meta-analysis. Acta Odontol Scand 1999;57(5): Limeback H, Ismail A, Banting D, DenBesten P, Featherstone J, Riordan PJ. Canadian Consensus Conference on the appropriate use of fluoride supplements for the prevention of dental caries in children. J Can Dent Assoc 1998;64(9): Nainar SM. Implications of evidence-based practice on preventive procedures in pediatric dentistry. Pediatr Dent 1997;19(6): Fluoride supplement dosage. British Dental Association, the British Society of Paediatric Dentistry and the British Association for the Study of Community Dentistry. Br Dent J 1997;182(1): Gillcrist JA. Recommendations for the appropriate use of fluoride products: Tennessee Department of Health. Tenn Med 1997;90(1): Fluoride supplementation for children: interim policy recommendations. American Academy of Pediatrics Committee on Nutrition. Pediatrics 1995;95(5): Ismail AI. Fluoride supplements: current effectiveness, side effects, and recommendations. Community Dent Oral Epidemiol 1994;22(3): Clark DC. Appropriate uses of fluorides for children: guidelines from the Canadian Workshop on the Evaluation of Current Recommendations Concerning Fluorides. Can Med Assoc J 1993;149(12):

4 Appendix 2 Excluded clinical studies published from June 1, 2006, to Dec. 11, 2009 For each identified clinical study, the expert panel (see Appendix 1) determined final exclusion of publications. They excluded publications on the basis of the following criteria: they did not directly address one of the identified clinical questions; the panelists had concerns about the methodology described. EXCLUDED ARTICLE Abell 1 Osso and Colleagues 2 Jenson and Colleagues 3 Ramos-Gomez and Colleagues 4 Naidoo and Myburgh 5 Garrison and Colleagues 6 Do and Spencer 7 Mjör 8 Steinberg 9 Keanie 10 Krol and Nedley 11 Hausen and Colleagues 12 Momeni and Colleagues 13 American Dental Association Division of Communications 14 Carrico 15 Sohn and Colleagues 16 Pieper and Colleagues 17 American Dental Association 18 Narendran and Colleagues 19 Hong and Colleagues 20 Australian Research Centre for RATIONALE FOR EXCLUSION Is not an intervention study Editorial comment Case report Study combined interventions including sealants No control group 4

5 Population Oral Health 21 Clark and Colleagues 22 Kumar and Moss 23 Wennhall and Colleagues 24 Ollila and Larmas 25 Do and Colleagues 26 Warren and Colleagues 27 No data regarding supplements Does not address the clinical question No data regarding supplements Does not address the clinical question 1. Abell S. Ask Dr. Sue: fluoride supplementation. Clin Pediatr (Phila) 2008;47(1): Osso D, Tinanoff N, Romberg E, Syme S, Roberts M. Relationship of naturally occurring fluoride in Carroll County, Maryland to aquifers, well depths, and fluoride supplementation prescribing behaviors. J Dent Hyg 2008;82(1): Jenson L, Budenz AW, Featherstone JD, Ramos-Gomez FJ, Spolsky VW, Young DA. Clinical protocols for caries management by risk assessment. J Calif Dent Assoc 2007;35(10): Ramos-Gomez FJ, Crall J, Gansky SA, Slayton RL, Featherstone JD. Caries risk assessment appropriate for the age 1 visit (infants and toddlers). J Calif Dent Assoc 2007;35(10): Naidoo S, Myburgh N. Nutrition, oral health and the young child. Matern Child Nutr 2007;3(4): Garrison GM, Loven B, Kittinger-Aisenberg LG. Clinical inquiries. Can infants/toddlers get enough fluoride through brushing? J Fam Pract 2007;56(9):752, Do LG, Spencer AJ. Risk-benefit balance in the use of fluoride among young children. J Dent Res 2007;86(8): Mjör IA. Fluoride and demineralization. JADA 2007;138(7): Steinberg S. A modern paradigm for caries management, part 2: a practical protocol. Dent Today 2007;26(6):76, Keanie H. Fluoride allergy. Br Dent J 2007;202(9): Krol DM, Nedley MP. Dental caries: state of the science for the most common chronic disease of childhood. Adv Pediatr 2007;54: Hausen H, Seppa L, Poutanen R, et al. Noninvasive control of dental caries in children with active initial lesions. A randomized clinical trial. Caries Res 2007;41(5): Momeni A, Hartmann T, Born C, Heinzel-Gutenbrunner M, Pieper K. Association of caries experience in adolescents with different preventive measures. Int J Public Health 2007;52(6): American Dental Association Division of Communications. For the dental patient: infants, formula and fluoride. JADA 2007;138(1): Carrico S. Fluoride: a review of therapeutic actions and use in infant oral health programs. J Mich Dent Assoc 2007;89(1):38, Sohn W, Ismail AI, Taichman LS. Caries risk-based fluoride supplementation for children. Pediatr Dent 2007;29(1): Pieper K, Born C, Hartmann T, Heinzel-Gutenbrunner M, Jablonski-Momeni A. Association of preventive measures with caries experience expressed by outcome variables. Schweiz Monatsschr Zahnmed 2007;117(10): American Dental Association. Interim guidance on reconstituted infant formula. J Okla Dent Assoc 2006;98(4):16. 5

6 19. Narendran S, Chan JT, Turner SD, Keene HJ. Fluoride knowledge and prescription practices among dentists. J Dent Educ 2006;70(9): Hong L, Levy SM, Broffitt B, et al. Timing of fluoride intake in relation to development of fluorosis on maxillary central incisors. Community Dent Oral Epidemiol 2006;34(4): Australian Research Centre for Population Oral Health. The use of fluorides in Australia: guidelines. Aust Dent J 2006;51(2): Clark DC, Shulman JD, Maupomé G, Levy SM. Changes in dental fluorosis following the cessation of water fluoridation. Community Dent Oral Epidemiol 2006;34(3): Kumar JV, Moss ME. Fluorides in dental public health programs. Dent Clin North Am 2008;52(2): , vii. 24. Wennhall I, Matsson L, Schroder U, Twetman S. Outcome of an oral health outreach programme for preschool children in a low socioeconomic multicultural area. Int J Paediatr Dent 2008;18(2): Ollila PS, Larmas MA. Long-term predictive value of salivary microbial diagnostic tests in children. Eur Arch Paediatr Dent 2008;9(1): Do LG, Spencer AJ, Ha DH. Association between dental caries and fluorosis among South Australian children. Caries Res 2009;43(5): Warren JJ, Levy SM, Broffitt B, Cavanaugh JE, Kanellis MJ, Weber-Gasparoni K. Considerations on optimal fluoride intake using dental fluorosis and dental caries outcomes: a longitudinal study. J Public Health Dent 2009;69(2):

7 Appendix 3 External reviewers The following scientific experts and organizations reviewed and commented on the evidencebased clinical recommendations for the prescription of dietary fluoride supplements (see main article online). These organizations do not necessarily endorse this document. The expert panel (see main article) considered all received comments carefully and made appropriate revisions in the recommendations. REVIEWER ORGANIZATION AND LOCATION Dr. Helen Whelton University Dental School and Hospital, Wilton, Cork, Ireland Dr. Deborah Matthews Dalhousie University, Halifax, Nova Scotia, Canada Dr. Philippe Hujoel University of Washington, Seattle Dr. James Bader University of North Carolina, Chapel Hill Dr. John Stamm University of North Carolina, Chapel Hill Dr. David Pendrys University of Connecticut, Farmington, Conn. Dr. Loc Do The University of Adelaide, Australia Dr. Jane Weintraub University of California, San Francisco Dr. John Spencer The University of Adelaide, Australia Dr. Woosung Sohn University of Michigan, Ann Arbor Dr. Rebecca L. Slayton University of Iowa College of Dentistry, Iowa City Dr. Karin Weber-Gasparoni University of Iowa College of Dentistry, Iowa City ORGANIZATIONS ORGANIZATION LOCATION American Academy of Pediatric Chicago Dentistry American Association of Public Springfield, Ill. Health Dentistry American Academy of Pediatrics Elk Grove Village, Ill. Association of State & Territorial Sparks, Nev. Dental Directors Agency for Healthcare Research and Rockville, Md. Quality American Dietetic Association Chicago Hispanic Dental Association Springfield, Ill. 7

8 Appendix 4 Description of publications included for evidence ISMAIL AND HASSON 1 (2008) Fluoride Supplements, Dental Caries and Fluorosis: A Systematic Review The authors of this systematic review examined the evidence for the effectiveness of dietary fluoride supplements in preventing caries and their association with dental fluorosis. In the review, they examined 20 reports regarding the effectiveness of fluoride supplements from 12 trials and five studies published since 1997 in which investigators evaluated the association between dental fluorosis and supplements. Ismail and Bandekar 2 reported in a 1999 review that the odds ratio of dental fluorosis in communities without fluoridated water was estimated to be about 2.5 among children who used fluoride supplements during the first six years of life. Of seven additional studies identified since then, the authors deemed five qualified for inclusion in their review. The additional studies confirmed the positive association between the use of fluoride supplements and dental fluorosis. The evidence supports the effectiveness of fluoride tablets in preventing caries primarily in providing a topical effect when used in school-aged children. The authors also found consistent evidence that use of fluoride supplements during the first years of life is associated with increased risk of fluorosis. Limitations of the evidence For children aged 6 months to 3 years, only one trial 3 provided information regarding the efficacy of dosage schedules similar to that recommended by the American Dental Association (ADA). 8

9 The large proportions of children who withdrew from using fluoride supplements in the included studies increased the potential for bias. There was no method of measuring fluorosis to assess the balance between esthetic acceptability and the risk of developing caries. Many of the included studies were conducted in the 1960s and 1970s and may have limited relevance today, given the almost universal use of fluoride toothpaste, the increase in water fluoridation and the halo effect. It is unclear as to what extent the investigators in all of these studies considered participants compliance with the prescribed regimen for dietary fluoride supplementation. BADER AND COLLEAGUES 4 (2004) Physicians Roles in Preventing Dental Caries in Preschool Children: A Summary of the Evidence for the U.S. Preventive Services Task Force The authors of this systematic review examined the evidence regarding the effectiveness of five preventive strategies that physicians can use in the management of early childhood caries: screening and risk assessment, referral, fluoride varnish application, parental counseling and prescribed fluoride drops or tablets. In their review, they addressed three questions related to the effectiveness of fluoride drops or tablets: appropriateness of supplementation decisions by providers; parental adherence to the dosage regimen; prevention of dental caries. 9

10 They identified published reviews of supplements or individual studies in MEDLINE for publications from 1966 to October They determined that investigators in 12 studies, most of which were surveys of providers, addressed the appropriateness of the prescription of fluoride tablets or drops by primary care clinicians. These studies provided evidence that physicians might not always make decisions on the basis of full knowledge of a child s other fluoride exposures. In their search, the authors did not identify any studies of providers effectiveness in achieving parental adherence to the daily dosage schedule. For the question regarding providers effectiveness in preventing dental caries, the authors identified six controlled prospective studies in which fluoride drops or tablets began before 5 years of age. Use of these agents was associated with reductions of 32 to 72 percent in the number of primary teeth affected by dental caries. Limitations of the evidence The findings of studies of appropriateness of fluoride prescription decisions were based primarily on providers self-reports and thus addressed patient-based decisions only indirectly. The authors found no evidence regarding providers effectiveness in gaining parental adherence to the dosage schedule. Clinical trials of caries-preventive measures were consistent in demonstrating benefits but generally were of fair-to-poor quality and typically used convenience samples without random assignment. In most clinical trials of caries prevention, investigators excluded participants from the analysis for nonadherence. 10

11 Participants dropout rates were high in clinical trials of caries prevention. ISMAIL AND BANDEKAR 2 (1999) Fluoride Supplements and Fluorosis: A Meta-Analysis This systematic review examined the evidence for an increased risk of dental fluorosis with regular use of fluoride supplements in communities without fluoridated water during tooth development. The prevalence of fluorosis in permanent teeth at various ages was the outcome measured. The review looked at 10 cross-sectional/case control studies and four follow-up studies that assessed the development of fluorosis in children. The authors found that the use of fluoride supplements in non-fluoridated communities during the first six years of life is associated with a significant increase in the risk of developing fluorosis. A meta-analysis for the follow-up studies showed a stronger association as the data used to determine exposure was based on records or detailed interviews rather than by recall of the parents or through selfadministered questionnaires as used in the cross-sectional studies. The degree of fluorosis observed in the studies was mostly very mild to mild. Toothbrushing with fluoride toothpaste increased the risk for children taking fluoride supplements (an additive effect observed). The authors concluded that owing to the risk of fluorosis, fluoride supplements should be targeted to children at high risk of experiencing caries. Limitations of the evidence No randomized clinical trials were included. The review did not address the effects of pre-eruptive versus posteruptive effects. 11

12 There was a potential for recall bias. The authors found it difficult to assess other fluoride exposures. There was significant variability in the study designs. There was variability in how fluorosis was measured in the studies cited. SPENCER AND DO 5 (2008) Changing Risk Factors for Fluorosis Among South Australian Children The authors of this study investigated changes in fluorosis associated with changes in fluoride exposures in Australia. They gathered the data from repeated cross-sectional surveys of children aged 5 to 17 years conducted in 1992 and 1993 (Child Fluoride Study [CFS] I) and 2002 and 2003 (CFS II) in South Australia. They assessed fluorosis by using the Thylstrup and Fejerskov index (TFI). They made comparisons for exposures to fluoride and also for fluorosis and risk factors. Prevalence of fluorosis with a TFI score greater than 0 on maxillary incisors for both studies are reported separately according to fluoridation status. They selected 797 children aged years from the cohort, of whom 375 received a fluorosis examination (47 percent); they selected 1,401 children aged 8-13 years from the cohort, of whom 677 received a fluorosis examination (52 percent). Overall fluorosis prevalence went down from 45 percent to 26 percent between the two study periods; fluorosis went from 49 percent to 30 percent in areas with fluoridated water and from 30 percent to 15 percent in areas without fluoridated water. Almost all of the fluorosis the authors found had a TFI score of 1. Increased risk of fluorosis development was consistent for fluoride supplements, fluoridated toothpaste and 12

13 fluoride concentration in toothpaste. The conclusion suggests that the observed reduction in fluorosis risk from 1993 through 2003 is likely caused by the introduction of 500-parts-permillion fluoride toothpaste and smaller amounts of dentifrice used, coupled with the use of a stricter fluoride supplement regimen in Australia. Limitations of the evidence Response rates were inadequate to permit valid definitive inferences (bias potential was present). Fluorosis assessment was restricted to the maxillary incisors, making it difficult to determine the overall pattern of fluorosis within the dentition for Australian children aged 8 to 15 years. Almost all of the fluorosis the authors found had a TFI score of 1; this level of fluorosis often is not perceptible except after the tooth is cleaned and dried. The specific effect of fluoride supplements is unclear, because these participants had multiple exposures to fluoride. PENDRYS AND COLLEAGUES 6 (2010) The Risk of Enamel Fluorosis and Caries Among Norwegian Children: Implications for Norway and the United States 5 The authors of this study investigated the association between enamel fluorosis, caries and early fluoride use among Norwegian children who received fluoride supplementation under a protocol similar to the protocol used in the United States. The data for these case-control studies were derived from a survey of middle school aged children living in Bergen, Norway. The 13

14 authors assessed dental caries by means of the decayed, missing, filled surfaces (DMFS) index. The authors used the Fluorosis Risk Index (FRI), which they used to categorize case and control participants based on fluorosis prevalence and severity separately for enamel zones that begin to form during the first (FRI I) or second (FRI II) years of life. Fluoride exposure was assessed by means of responses to a questionnaire mailed to parents to assess drinking water source, dietary supplement usage frequency during each year for the first 8 years of life and collectively for the period from age 9 years to the time of the survey; the usual amount of toothpaste used for brushing, and various other factors. Ultimately, the authors included 660 child participants in the analysis because they had undergone an oral examination, had parents who received and responded to the survey, and met the study s residency criterion. Mild to moderate fluorosis was rare (1 percent of participants in FRI I and 2 percent of those in FRI II). Cases of less severe fluorosis were more prevalent (10 percent among participants in FRI I, 18 percent among those in FRI II). The authors concluded that regular use of fluoride supplements was the only important risk factor for mild to moderate fluorosis on early-forming tooth surfaces (FRI I). Dietary fluoride supplementation for both study periods during the ages from 48 to 72 months was associated with mild to moderate fluorosis (odds ratio [OR] = 6.85 for FRI I; OR = for FRI II). Use of more than a pea-sized amount of dentifrice during the first 24 months also was associated with fluorosis on FRI II enamel surface zones, but the study sample included only a small number of participants with this exposure (n = 3). Regular use of dietary fluoride supplements for six or more years was associated with an estimated 46 percent reduction in 14

15 caries risk. However, no statistically significant caries benefit from dietary fluoride supplements could be demonstrated until participants had used supplements for six years or longer. Limitations of the evidence There was likely confounding for fluorosis risk between use of more than a pea-sized amount of toothpaste and use of fluoride supplements. In addition, the authors presented no data regarding dentifrice use between the ages from birth and 24 months, which is a potential confounding factor for fluorosis risk. There is potential recall bias by parents when completing the questionnaire. The exact nature of control groups used for the study is unclear. There are uncertainties about internal/external validity and bias owing to the inclusion of 660 of 2,106 consenting participants and an unspecified consent rate for the initial sample. The small number of fluorosis cases limited the study s statistical power and the authors ability to assess possible interactions between fluoride sources. 1. Ismail AI, Hasson H. Fluoride supplements, dental caries and fluorosis: a systematic review. JADA 2008;139(11): Ismail AI, Bandekar RR. Fluoride supplements and fluorosis: a meta-analysis. Community Dent Oral Epidemiol 1999;27(1): Hu D, Wan H, Li S. The caries-inhibiting effect of a fluoride drop program: a 3-year study on Chinese kindergarten children. Chinese J Dent Res 1998;1(3): Bader JD, Rozier RG, Lohr KN, Frame PS. Physicians' roles in preventing dental caries in preschool children: a summary of the evidence for the U.S. Preventive Services Task Force. Am J Prev Med 2004;26(4): Spencer AJ, Do LG. Changing risk factors for fluorosis among South Australian children. Community Dent Oral Epidemiol 2008;36(3): Pendrys DG, Haugejorden O, Bardsen A, Wang NJ, Gustavsen F. The risk of enamel fluorosis and caries among Norwegian children: implications for Norway and the United States. JADA 2010;141(4):