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Topical fluoride for caries prevention:
executive summary of the updated
clinical recommendations and
supporting systematic review.
Weyant RJ et al.
J Am Dent Assoc 2013;144(11):1279-1291

Applying Prescription-strength Home-use

and Professionally Applied Topical Fluoride
Products May Benefit People at High Risk
for Caries The American Dental
Association (ADA) 2013 Clinical Practice
Guideline Recommendations



Valeria C.C. Marinho, BDS, MSc, PhD

Selection Criteria

The purpose of this executive summary
report is to present recommendations
regarding professionally applied and
prescription-strength home-use topical
fluoride products for caries prevention in
children and adults based on a
systematic review of trials. It updates the
American Dental Association (ADA)
2006 clinical recommendations on
topical fluorides

The American Dental Association
(ADA) Council on Scientific Affairs
(CSA) Expert Panel on Topical Fluoride
Agents commissioned this study, which
was supported in part by the Centers for
Disease Control and Prevention.

A clinical practice guideline which
includes a supporting systematic review
(with meta-analysis of trials data) upon
which the recommendations are based

A multidisciplinary panel of experts was convened by the American Dental

Association (ADA) Council on Scientific Affairs (CSA) to conduct the
review and develop the recommendations. They produced this executive
summary and a full report that is available at the ADA Center for
Evidence-based Dentistry website (
Three questions guided the selection and review of relevant research
evidence for the development of the recommendations in the guideline:
(1) In primary and permanent teeth, does the use of a topical fluoride
compared to no topical fluoride reduce the incidence of new lesions, or
arrest or reverse existing coronal and/or root caries? (2) For primary
and permanent teeth, is one topical fluoride agent more effective than
another in reducing the incidence of, or arresting or reversing coronal
and/or root caries? (3) Does the use of prophylaxis before application of
topical fluoride reduce the incidence of caries to a greater extent than
topical fluoride application without prophylaxis? However, the panel did
not consider the question on the comparative effectiveness of different
fluoride agents (2) further because insufficient evidence was found on
which to base clinical recommendations.
For the supporting systematic review conducted as part of the clinical
practice guideline development process, MEDLINE and The Cochrane
Library were searched for controlled trials (randomized and nonrandomized) of professionally applied and prescription-strength topical
fluoride agents (sodium, stannous, and acidulated phosphate fluoride)
included in mouthrinses, varnishes, gels, foams, and prophylaxis pastes
with caries increment outcomes. The search covered articles published in
English only, through October 2012.

Level 1: Good-quality, patient-oriented

Grade A: Consistent, good-quality
patient-oriented evidence
J Evid Base Dent Pract 2014;14:120-123
2014 Elsevier Inc. All rights reserved.

Key Study Factor

The use of specific topical fluoride agents (sodium, stannous, and acidulated phosphate fluoride) in professionally applied and prescriptionstrength, home-use topical fluoride products (mouthrinses, varnishes,
gels, foams, and prophylaxis pastes) by people at a high risk of developing
caries was the focus of the report.
The methodology for the ADA 2013 recommendations on topical fluoride products followed the guides set out in the ADA Clinical Practice
Guidelines Handbook that is available at the ADA Center for EBD webpage


Caries increment was the outcome measure addressed in

the report. The panel was also interested in the effect of
topical fluoride agents on the arrest and reversal of caries
progression as indicated in the questions above, but
because insufficient evidence was found on these outcomes, the panel focused the clinical recommendations
on the reduction of caries increment only, and these outcomes were not addressed in the recommendations.

For Those Younger Than Age 6 Years. Only 2.26%

fluoride varnish professionally applied at least every
36 months is recommended.
The panel highlighted that those at low risk of developing caries (including people living in optimally fluoridated areas and using fluoridated toothpaste) may not
need such additional topical fluoride treatments.
The panel pointed out that the use of prior prophylaxis
before 1.23% fluoride (APF) gel application for coronal
caries prevention is not necessary (in all age groups).
The strength of the clinical recommendations for the
fluoride agents varied from in favor to expert opinion
for, according to the level of evidence to support the
intervention being recommended, and such variations
were mainly related to the fact that the evidence base is
more developed for children than for adults.
Recommendations for future trials were made by the
panel according to the following areas of research: mechanism of topical fluoride action (under background fluoride exposure), caries outcome measurements (arrest,
reversals), population groups (adults, high-risk, and special needs populations), specific fluoride products and
ways of use, economic data, and implementation (use of
recommendations in practice).

Main Results


The systematic review included 71 trials (from 82 published papers) on the various relevant topical fluoride
treatment agents for preventing caries, with meta-analysis
being undertaken where appropriate.
Based on the review findings, the expert panel concluded
that some professionally applied and prescription-strength
topical fluoride agents are efficacious in preventing and
controlling caries. These products include 2.26% fluoride varnishes, 1.23% fluoride gels, prescription-strength,
home-use 0.5% fluoride gels/pastes, and prescriptionstrength, home-use 0.09% fluoride mouthrinses. The review panel did not find that 0.1% fluoride varnishes or
prophylaxis pastes containing fluoride were efficacious in
preventing caries, and found insufficient evidence on the
efficacy of 1.23% fluoride foams in caries prevention.
The panel found insufficient evidence on the comparative caries-preventive efficacy of topical fluoride agents,
no caries-preventive benefit from conducting a prophylaxis prior to APF gel (1.23% fluoride) application, and
no evidence on the effect of prior prophylaxis for other
topical fluoride agents.
The main clinical recommendations for people at high
caries risk were:

Based on the evidence reviewed, the use of the following

fluoride products by people at high caries risk is recommended by the panel according to specific age groups
and frequencies of application: 2.26% fluoride varnishes,
1.23% fluoride gels, prescription-strength home-use 0.5%
fluoride gels or pastes, and prescription-strength homeuse 0.09% fluoride mouthrinses.
As part of the evidence-based approach to care, the
panel highlighted that the clinical recommendations
should be integrated with the practitioners professional
judgment and the patients needs and preferences.

In short, based on the summary of results from the supporting systematic review, which included meta-analyses of
trial data on the various topical fluoride caries preventive
agents, evidence statements were developed with a corresponding level of certainty (high, moderate, or low) for
each relevant fluoride agent according to age group or
dentition affected. The clinical recommendations for
their use were then developed for each age group, and
the strength of the recommendations was graded according to a standardized process. It balanced level of certainty
and net benefit rating (based on the balance of benefits
and potential harms) to arrive at recommendation
strength. Recommendations for future research were
also developed.

Main Outcome Measure

For Those 6 Years or Older. 2.26% fluoride varnish

professionally applied at least every 36 months or
1.23% fluoride (APF) gel professionally applied for 4 minutes at least every 36 months; home-use of 0.09% fluoride mouthrinse at least weekly, or home-use of 0.5%
fluoride gel or paste twice daily.
Volume 14, Number 3


The 2013 recommendations developed by a multidisciplinary panel of experts convened by the American
Dental Association (ADA) Council on Scientific Affairs
(CSA) provide evidence-based guidance to help practitioners make decisions about the use of selected topical
fluoride treatments for caries prevention in children
and adults at elevated risk of developing caries. The
guideline is an update of the ADA 2006 clinical recommendations, where the links between the supporting evidence and the recommendations are clearly presented, as
was the case in its first version. The caries preventive effect
of prescription-strength home-use fluoride products is
addressed now, in addition to the professionally applied
treatment modalities covered in the previous guideline.
Also, rather than using existing systematic reviews as sources to provide the evidence base for formulating specific


recommendations within the guideline as was the case in

the 2006 version, a new review of primary studies was
undertaken; a different grading system was also used for
assessing the body of the evidence and strength of recommendations in the 2013 report.
Guidelines in clinical practice may help translate
research findings into health gain, as their role is to provide a comprehensive, critical summary of the research
evidence in the form of easily implemented recommendations for clinical care.1 During the last two decades there
has been much interest in the development of evidencebased guideline recommendations and of systematic
reviews summarizing research findings. Systematic reviews are crucial to making the vast amount of health
care research evidence manageable and valid research
findings available for decision-makers, helping directly
in the formulation of evidence-based practice guidelines.
Undertaking and maintaining systematic reviews of high
quality is a resource-intensive and complex task, and the
Cochrane Collaboration is the worlds largest organization dedicated to this type of activity, producing internationally relevant systematic reviews across most fields of
health care ( The development of clinical practice guidelines is also complex and
requires various steps beyond a systematic review, as
guidelines generally incorporate judgments and values
of clinicians, patients, and other stakeholders when
providing recommendations to assist decision-making
that can result in the improvement of care and outcomes.
The methodology for conducting reviews and guidelines
is constantly improving. Cochrane methods for systematic
reviews are well developed, and there is a move toward using a new method in assessing the body of evidence for
guideline development the GRADE approach.2 The
Grading of Recommendations Assessment, Development
and Evaluation (GRADE) approach provides a system for
rating quality of evidence and strength of recommendations that is explicit and pragmatic and is increasingly
being adopted by organizations worldwide. In addition,
an instrument is available for improving the quality and
effectiveness of clinical practice guidelines the AGREE
checklist (for the Appraisal of Guidelines Research and
Evaluation see This
tool evaluates each step of the guideline development
process, which includes scope and purpose, stakeholder
involvement, rigor of development, clarity of recommendations, applicability, and editorial independence.
That said, although the GRADE process was not
employed for this guideline, the approach for the development of the guideline using ADA methodology has
been systematic, with a full description of the methods
adopted in each step of the process. These included information describing who was involved, how the evidence
was retrieved and assessed, how the body of evidence
was considered and synthesized, and how the strength
of the body of evidence was graded and recommendation

decisions were made. As for the scope and purpose of the

ADA 2013 guideline recommendations, although these
are well described, the title of the study could reflect its
current remit more precisely by indicating the general
types of topical fluoride considered (professionally
applied and prescription strength fluoride for home
use), as well as the population group ultimately addressed
in the recommendations for caries prevention (children
and adults at high risk of developing caries). Regarding
stakeholder involvement, there is no indication of widespread consultation with professional groups and organizations outside the specialty, or the United States, and no
indication of patient involvement in the development of
the recommendations, but the disclosures declared
from panel members made the process more transparent.
In addition, it was pointed out that the external peer
review undertaken has resulted in improvements in the
The Scottish Intercollegiate Guidelines Network
(SIGN) have also launched a new guideline on caries prevention recently,3 which replaces two previous guidelines:
SIGN 47 on preventing dental caries in children at high
caries risk and SIGN 83 on the prevention and management of dental decay in the preschool child. There is
some overlap between the current SIGN and ADA guidelines for topical anticaries interventions, more specifically
on the key recommendations for the use of fluoride varnishes. However, the ADA guidance includes the evidence
and recommendations relating to people over age
18 years, and it should be noted that those for the use
of 2.26% varnish in this age group for coronal caries is
largely extrapolated from the data available for the effectiveness of fluoride varnishes in the younger age groups
(6- through 18-year-olds) and from scarce data on root
caries. In addition, besides the statement in the ADA
report that the current evidence-based recommendations
are not intended to define a standard of care and that
they should be balanced with each practitioners professional judgment and the patients condition, needs, and
preferences, the report briefly emphasizes that in public
health care settings, additional considerations include
the feasibility and cost of the proposed intervention.
Nevertheless, these issues were not considered when
providing the clinical recommendations, whereas SIGN
includes some information on the potential resources implications of the key recommendations and provides suggestions for auditing to assist with the implementation of
the recommendations. Perhaps these could be considered in future ADA guidance.
The availability of a full report that supplements the executive summary is a helpful characteristic of the ADA
guidance. The full report describes the study focus (questions/outcomes) in detail, as well as the complete search
and methodology adopted for the supporting systematic
review carried out as part of the guideline and updated
recommendations. For example, it is made explicit in
September 2014


the full report that clinically relevant outcomes considered from the outset in the guideline, included caries
increment, arrest, and reversal, and that only caries increment was ultimately addressed in the recommendations
due to insufficient evidence on the others. Thus the relative values of the outcomes could not be weighed in terms
of importance. It is also pointed out in the full report that
three clinical questions are addressed in the study, but
because insufficient evidence was found on one of the
questions the comparative effectiveness of different
topical fluoride agents it was not considered further.
Here, a relevant Cochrane review 4 that compiles experimental evidence on this comparison might have been
considered among the reviews used in the guideline as
a source to identify relevant trials for the supporting
The full report also exposes areas where some refinements could have been beneficial in the conduct of the
systematic review and the subsequent interpretation of
the evidence. With this regard, issues on the searches performed to locate primary studies for the review and on the
methods adopted to compile and summarize some of the
data in the review may have had an impact on the data
available (or lack of data) for analysis and on how these
were used in the recommendations. For example, relevant trials may have gone unidentified for the supporting
review because the search is limited to studies in the English language, where only two databases appear to have
been searched, and because the strategy could probably
have been more sensitive. On the other hand, irrelevant
trial arms may have contributed results for analysis
because positive control group data that did not address
the questions posed in the systematic review appear to
have been pooled.
Because caries prevention is an area in which a sizeable
body of evidence is compiled systematically by the

Volume 14, Number 3

Cochrane Collaboration, perhaps greater international

collaboration between guideline development organizations such as the ADA and Cochrane groups such as the
Oral Health Group could be considered in the future to
facilitate such refinements in the systematic review underpinning the recommendations. Bearing in mind that this
is not a suggestion that all clinical guidelines must use
Cochrane systematic reviews as their primary source of
evidence and that guideline developers can and should
make recommendations that are specific to local contexts, such collaboration can improve the efficiency in
the use of research resources to make relevant and valid
summaries of the evidence available internationally.

1. Shiffman RN, Shekelle P, Overhage JM, Slutsky J, Grimshaw J,
Deshpande AM. Standardized reporting of clinical practice guidelines: a proposal from the conference on guideline standardization.
Ann Intern Med 2003;139:493-8.
2. Guyatt GH, Oxman AD, Vist GE, et al. GRADE: an emerging
consensus on rating quality of evidence and strength of recommendations. BMJ 2008;336:924-6.
3. Scottish Intercollegiate Guidelines Network (SIGN). Dental Interventions to Prevent Caries in Children. Edinburgh: SIGN; 2014 (SIGN
publication no. 138).
4. Marinho VCC, Higgins JPT, Sheiham A, Logan S. One topical fluoride
(toothpastes, or mouthrinses, or gels, or varnishes) versus another for
preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2004;(1):CD002780.

Valeria C.C. Marinho, BDS, MSc, PhD
Senior Lecturer, Institute of Dentistry, Barts and The London
School of Medicine and Dentistry, Queen Mary University of
London, Turner Street, Whitechapel, London E1 1BB, UK,
Tel.: 44 (0)20 7882 8671