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Guideline Summary
Guideline Title
Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention. A report of the American Dental Association Council on Scientific Affairs.
Bibliographic Source(s)
Rozier RG, Adair S, Graham F, Iafolla T, Kingman A, Kohn W, Krol D, Levy S, Pollick H, Whitford G, Strock S, Frantsve-Hawley J, Aravamudhan K, Meyer DM. Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2010 Dec;141(12):1480-9. [73 references] PubMed External Web Site Policy
Guideline Status

This is the current release of the guideline.

Scope

Disease/Condition(s)

Dental caries

Guideline Category
Assessment of Therapeutic Effectiveness
Prevention
Risk Assessment
Clinical Specialty
Dentistry
Family Practice
Pediatrics
Preventive Medicine
Intended Users
Advanced Practice Nurses
Dentists
Health Care Providers
Physician Assistants
Physicians
Public Health Departments
Guideline Objective(s)
  • To provide recommendations for when and for whom fluoride supplements should be prescribed
  • To provide a recommended dosage schedule for dietary fluoride supplements
Target Population

Infants and children aged 6 months to 16 years who live in communities without fluoridated water or with water of low fluoride content

Interventions and Practices Considered
  1. Evaluation of all potential fluoride sources and conducting a caries risk assessment before prescribing fluoride supplements
  2. Prescription of dietary fluoride supplements for children at high risk of developing caries
  3. Daily fluoride supplementation with dosage based on child's age and fluoride concentration in drinking water
Major Outcomes Considered

Occurrence of dental fluorosis and dental caries in infants and children aged 6 months to 16 years

Methodology

Methods Used to Collect/Select the Evidence
Hand-searches of Published Literature (Primary Sources)
Searches of Electronic Databases
Description of Methods Used to Collect/Select the Evidence

A panel of experts convened by the American Dental Association (ADA) Council on Scientific Affairs (CSA), in collaboration with staff of the ADA Center for Evidence-based Dentistry, conducted a MEDLINE search to identify publications that addressed the research questions: systematic reviews as well as clinical studies published since the systematic reviews were conducted (June 1, 2006).

Search Strategies

Systematic Reviews

ADA staff conducted a literature search for systematic reviews published in English as of May 14, 2008, by using PubMed and the following search terms: "fluoride supplements," "vitamin" OR "fluoride supplements," "tablet" OR "fluoride supplements," "chewable" OR "fluoride supplements," "drop" OR "fluoride supplements," "lozenges" AND "dental caries" OR "demineralization" OR "remineralization" OR "cariostatic" OR "anticaries" (tw) OR "anticaries" (tw) OR "fluorosis," "dental" OR "fluorosis," "enamel" OR "mottled" AND "systematic" (sb). (Note: "tw" means "text word"; "sb" means "subset.")

Two investigators on the ADA staff conducted the search on May 14, 2008. The initial search yielded 136 articles. The same two investigators conducted a title review for relevance to the clinical questions. They identified 46 articles. They also screened abstracts of these 46 articles, which yielded 23 articles for consideration. They conducted a full-text review of the 23 articles. Their reviews included systematic reviews that either included or did not include meta-analyses, as evidenced by use of the terms in the publication, or that had key features of a systematic review such as a comprehensive literature search and two independent reviewers. Inclusion criteria were as follows:

  • Human participants
  • Publication in the English language
  • Patients who had been exposed to fluoride supplements
  • Evidence provided to answer the clinical questions
  • Reported outcomes of either caries or enamel fluorosis
  • Examination of patients to determine presence of caries or enamel fluorosis
  • For caries-prevention studies, a study design that included both control and experimental groups.

Ultimately, the two investigators included two systematic reviews for consideration by the expert panel. The investigators also included for the panel's review a systematic review by Ismail and colleagues that had been accepted for publication but not yet published.

Appendix 1 in the supplemental data to the online version of this article (see the "Availability of Companion Documents" field) provides the complete list of the excluded publications.

One of the authors updated the literature search for systematic reviews to include only articles published between May 14, 2008, and Dec. 11, 2009. She used the same search terms as described above. She and another independent reviewer identified and screened 23 citations (full text and abstract). They did not identify any new systematic reviews. Then she conducted the search again to include only articles published between Dec. 11, 2009, and June 16, 2010, using the same search terms as described above. She and the other independent reviewer identified and screened the abstracts of three citations. They did not identify any new systematic reviews.

Clinical Studies

Two researchers searched for recently published clinical studies related to the clinical questions. They conducted their search on the basis of the search date used in the most recent systematic review, which Ismail and Hasson published in 2008. In that systematic review, the authors conducted a literature search on June 1, 2006. Thus, the researchers limited their search to articles published from June 1, 2006, through May 14, 2008. The two researchers conducted a literature search for clinical studies published in English by using PubMed and the following search terms: "fluoride supplements," "vitamin" OR "fluoride supplements," "tablet" OR "fluoride supplements," "chewable" OR "fluoride supplements," "drop" OR "fluoride supplements," "lozenges" AND "dental caries" OR "demineralization" OR "remineralization" OR "cariostatic" OR "anti-caries" (tw) OR "anticaries" (tw) OR "fluorosis," "dental" OR "fluorosis," "enamel" OR "mottled." The initial search yielded 987 articles. The researchers screened titles and reduced the number to 51 clinical studies that related to the clinical questions. Screening of the abstracts yielded 25 articles for full-text review, two of which the researchers included for consideration by the expert panel but which, ultimately, the panel excluded because they were not relevant to the clinical question.

The inclusion criteria were as described earlier for the systematic review search. Appendix 2 in the supplemental data to the online version of this article (see the "Availability of Companion Documents" field) provides the complete list of excluded publications.

One of the authors updated the literature search for clinical studies to include only articles published between May 14, 2008, and Dec. 11, 2009. She used the same search terms as described above. She and another independent reviewer identified and screened 754 citations (titles and abstracts). They selected three articles for full-text review. Of these, the panel considered only one study that met the inclusion criteria. The panel became aware of one additional report that had been accepted for publication, but not yet published, by The Journal of the American Dental Association. The panel included these two studies.

Then the same author updated the literature search for clinical studies published between Dec. 11, 2009, and June 16, 2010. She used the same search terms as described above. She and the other independent reviewer identified and screened 222 citations (titles and abstracts). They identified no additional studies.

Number of Source Documents

The panel included in its evaluations three systematic reviews and two clinical studies related to the clinical questions.

Methods Used to Assess the Quality and Strength of the Evidence
Weighting According to a Rating Scheme (Scheme Given)
Rating Scheme for the Strength of the Evidence
Level Category of Evidence
Ia Evidence from systematic reviews of randomized controlled trials
Ib Evidence from at least one randomized controlled trial
IIa Evidence from at least one controlled study without randomization
IIb Evidence from at least one other type of quasi-experimental study, such as time series analysis or studies in which the unit of analysis is not the individual
III Evidence from nonexperimental descriptive studies, such as comparative studies, correlation studies, cohort studies and case-control studies
IV Evidence from expert committee reports or opinions or clinical experience of respected authorities

*Amended with permission of the British Medical Journal (BMJ) Publishing Group from Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. Brit Med J 1999;318(7183):593-6.

Methods Used to Analyze the Evidence
Review of Published Meta-Analyses
Systematic Review with Evidence Tables
Description of the Methods Used to Analyze the Evidence

The panel performed a qualitative assessment of the strengths and limitations of each included systematic review or clinical study to determine the quality of the evidence. The panel developed evidence statements that were based on the literature, then graded the evidence according to a system modified by Shekelle and colleagues (see the "Rating Scheme for the Strength of the Evidence" field).

The panelists also analyzed the individual studies in the systematic reviews in which investigators addressed caries prevention, looking for evidence related to specific schedules according to age group and level of fluoride in the community water supply. The included studies were not limited to the United States and were conducted in areas with varying levels of fluoride in the community water supply. Appendices 1 and 2 in the supplemental data to the online version of this article (see the "Availability of Companion Documents" field) list the excluded publications. The panelists considered the body of evidence and drafted the evidence statements listed in Table 2 in the original guideline document. Although investigators in many of the included studies addressed the clinical questions, many of the studies had methodological limitations. Also, some are from an earlier era of fluoride supplement research, during which caries incidence was higher and there were fewer sources of fluoride exposure than there are now.

Methods Used to Formulate the Recommendations
Expert Consensus (Consensus Development Conference)
Description of Methods Used to Formulate the Recommendations

Expert Panel

In July 2008, the American Dental Association (ADA) Council on Scientific Affairs (CSA) convened an expert panel to develop recommendations addressing the following questions:

  • When and for whom should fluoride supplements be prescribed?
  • What should be the recommended dosage schedule for dietary fluoride supplements?

The panel of 10 experts evaluated systematically the collective scientific evidence related to the clinical questions listed above and developed evidence-based clinical recommendations for the prescription of dietary fluoride supplements.

The Council selected panelists on the basis of their expertise in the relevant subject matter. The expert panel convened at a workshop held July 16-18, 2008, at the ADA Headquarters in Chicago. The panelists continued their work by means of conference calls to finalize the recommendations and develop this report.

Grading the Evidence and Classifying the Strength of the Clinical Recommendations

The panel performed a qualitative assessment of the strengths and limitations of each included systematic review or clinical study to determine the quality of the evidence. The panel developed evidence statements that were based on the literature, then graded the evidence according to a system modified by Shekelle and colleagues (see the "Rating Scheme for the Strength of the Evidence" field). The panel then developed the clinical recommendations according to the evidence statements.

Using the same modified system (see the "Rating Scheme for the Strength of the Recommendations" field), the panel classified the clinical recommendations on the strength of the evidence reviewed. Although the classification of the recommendation may not directly reflect the importance of the recommendation, it does reflect the quality of scientific evidence that supports the recommendation.

Rating Scheme for the Strength of the Recommendations
Classification Strength of Recommendations
A Directly based on category I evidence
B Directly based on category II evidence or extrapolated recommendation from category I evidence
C Directly based on category III evidence or extrapolated recommendation from category I or II evidence
D Directly based on category IV evidence or extrapolated recommendation from category I, II, or III evidence

*Amended with permission of the British Medical Journal (BMJ) Publishing Group from Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. Brit Med J 1999;318(7183):593-6.

Cost Analysis

A formal cost analysis was not performed and published cost analyses were not reviewed.

Method of Guideline Validation
External Peer Review
Internal Peer Review
Description of Method of Guideline Validation

Appendix 3 in the supplemental data online (see the "Availability of Companion Documents" field) lists the numerous scientific experts and organizations that reviewed this document. The panelists evaluated all comments received and made appropriate revisions. The Council on Scientific Affairs approved the final clinical recommendations.

Recommendations

Major Recommendations

The levels of evidence (Ia-IV) and the classification of recommendations (A-D) are defined at the end of the "Major Recommendations" field.

Clinical Recommendations for the Use of Dietary Fluoride Supplements
The expert panel convened by the American Dental Association Council on Scientific Affairs developed the following recommendations. They are intended as a resource for dentists and other health care providers. The recommendations must be balanced with the practitioner's professional judgment and the individual patient's needs and preferences.

Children are exposed to multiple sources of fluoride. The expert panel encourages health care providers to evaluate all potential fluoride sources and to conduct a caries risk assessment before prescribing fluoride supplements.
RECOMMENDATION STRENGTH OF RECOMMENDATIONS
For children at low risk of developing caries, dietary fluoride supplements are not recommended and other sources of fluoride should be considered as a caries-preventive intervention. D
For children at high risk of developing caries, dietary fluoride supplements are recommended according to the schedule presented in the table below. D
When fluoride supplements are prescribed, they should be taken daily to maximize the caries-preventive benefit. D
RECOMMENDED AMERICAN DENTAL ASSOCIATION DIETARY FLUORIDE SUPPLEMENT DOSING SCHEDULE FOR CHILDREN AT HIGH RISK OF DEVELOPING CARIES
Age (Years) Amount of Fluoride Supplementation and Strength of Recommendations, According to Fluoride Concentration in Drinking Water (Parts per Million*)
<0.3 0.3-0.6 >0.6
Fluoride Supplementation Strength of Recommendations Fluoride Supplementation Strength of Recommendations Fluoride Supplementation Strength of Recommendations
Birth to 6 months None D None D None D
6 months to 3 years 0.25 milligrams per day B None D None D
3 to 6 years 0.50 mg/day B 0.25 mg/day B None D
6 to 16 years 1.00 mg/day B 0.50 mg/day B None D
*1.0 part per million=1 milligram per liter

Definitions:

Levels of Evidence

Level Category of Evidence
Ia Evidence from systematic reviews of randomized controlled trials
Ib Evidence from at least one randomized controlled trial
IIa Evidence from at least one controlled study without randomization
IIb Evidence from at least one other type of quasi-experimental study, such as time series analysis or studies in which the unit of analysis is not the individual
III Evidence from nonexperimental descriptive studies, such as comparative studies, correlation studies, cohort studies and case-control studies
IV Evidence from expert committee reports or opinions or clinical experience of respected authorities

*Amended with permission of the British Medical Journal (BMJ) Publishing Group from Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. Brit Med J 1999;318(7183):593-6.

Classification of Recommendations

Classification Strength of Recommendations
A Directly based on category I evidence
B Directly based on category II evidence or extrapolated recommendation from category I evidence
C Directly based on category III evidence or extrapolated recommendation from category I or II evidence
D Directly based on category IV evidence or extrapolated recommendation from category I, II, or III evidence

*Amended with permission of the British Medical Journal (BMJ) Publishing Group from Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical guidelines: developing guidelines. Brit Med J 1999;318(7183):593-6.

Clinical Algorithm(s)

None provided

Evidence Supporting the Recommendations

Type of Evidence Supporting the Recommendations

The type of supporting evidence is identified and graded for each recommendation (see the "Major Recommendations" field).

Benefits/Harms of Implementing the Guideline Recommendations

Potential Benefits
  • Appropriate use of fluoride supplements
  • Decrease in dental caries and fluorosis
Potential Harms
  • The use of dietary fluoride supplements during tooth development increases the potential risk of developing very mild to mild enamel fluorosis.
  • Inappropriate prescription of dietary fluoride supplements during the first years of life in an area with optimally fluoridated water is associated with mild to moderate enamel fluorosis.

Qualifying Statements

Qualifying Statements

The clinical recommendations are intended as a resource for use by dentists and other health care providers. The recommendations must be balanced with the practitioner's professional judgment and the individual patient's needs and preferences. The scope of review for this panel did not include recommendations for school-based or other dental public health programs such as the federal Head Start program.

Implementation of the Guideline

Description of Implementation Strategy

An implementation strategy was not provided.

Implementation Tools
Patient Resources
Quick Reference Guides/Physician Guides
For information about availability, see the Availability of Companion Documents and Patient Resources fields below.

Institute of Medicine (IOM) National Healthcare Quality Report Categories

IOM Care Need
Staying Healthy
IOM Domain
Effectiveness
Patient-centeredness
Safety

Identifying Information and Availability

Bibliographic Source(s)
Rozier RG, Adair S, Graham F, Iafolla T, Kingman A, Kohn W, Krol D, Levy S, Pollick H, Whitford G, Strock S, Frantsve-Hawley J, Aravamudhan K, Meyer DM. Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention: a report of the American Dental Association Council on Scientific Affairs. J Am Dent Assoc. 2010 Dec;141(12):1480-9. [73 references] PubMed External Web Site Policy
Adaptation

Not applicable: The guideline was not adapted from another source.

Date Released
2010 Dec
Guideline Developer(s)
American Dental Association - Professional Association
Source(s) of Funding

American Dental Association

Guideline Committee

American Dental Association Council on Scientific Affairs Expert Panel

Composition of Group That Authored the Guideline

Panel Members: R. Gary Rozier, DDS, MPH; Steven Adair, DDS, MS; Frank Graham, DMD; Timothy Iafolla, DMD, MPH; Albert Kingman, PhD; William Kohn, DDS; David Krol, MD, MPH; Steven Levy, DDS, MPH; Howard Pollick, BDS, MPH; Gary Whitford, PhD, DMD; Sheila Strock, DMD, MPH; Julie Frantsve-Hawley, RDH, PhD; Krishna Aravamudhan, BDS, MS; Daniel M. Meyer, DDS

Financial Disclosures/Conflicts of Interest

The panel comprised 10 members who represented a broad range of expertise in dentistry, children's oral health or both. All panelists completed a standard conflict-of-interest questionnaire.

Disclosures

Dr. Adair is the chief dental officer, FORBA Dental Management, Nashville. None of the other authors reported any disclosures.

Guideline Status

This is the current release of the guideline.

Guideline Availability

Electronic copies: Available in Portable Document Format (PDF) from the American Dental Association Web site External Web Site Policy.

Print copies: Available from the American Dental Association, 211 E. Chicago Avenue, Chicago, IL 60611

Availability of Companion Documents

The following are available:

  • Evidence-based clinical recommendations on the prescription of dietary fluoride supplements for caries prevention supplemental data. A report of the American Dental Association Council on Scientific Affairs; 2010. 15 p. Electronic copies: Available in Portable Document Format (PDF) from the American Dental Association (ADA) Web site External Web Site Policy.
  • Dietary fluoride supplements: evidence-based clinical recommendations. Chair-side guide. American Dental Association Council on Scientific Affairs; 2010. 2 p. Electronic copies: Available in PDF from the ADA Web site External Web Site Policy.
Patient Resources

The following are available:

Please note: This patient information is intended to provide health professionals with information to share with their patients to help them better understand their health and their diagnosed disorders. By providing access to this patient information, it is not the intention of NGC to provide specific medical advice for particular patients. Rather we urge patients and their representatives to review this material and then to consult with a licensed health professional for evaluation of treatment options suitable for them as well as for diagnosis and answers to their personal medical questions. This patient information has been derived and prepared from a guideline for health care professionals included on NGC by the authors or publishers of that original guideline. The patient information is not reviewed by NGC to establish whether or not it accurately reflects the original guideline's content.

NGC Status

This NGC summary was completed by ECRI Institute on January 31, 2012. The information was verified by the guideline developer on February 8, 2012.

Copyright Statement

This NGC summary (abstracted American Dental Association Guideline) is based on the original guideline, which is subject to the guideline developer's copyright restrictions.

Content contained within the original guideline and/or the NGC Summary of this guideline may not be used for commercial and/or product endorsement.

All other copyright rights in the American Dental Association Guidelines are reserved by the American Dental Association. For information concerning terms governing downloading, use, and reproduction of these guidelines contact the American Dental Association.

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