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## Complete Summary

#### GUIDELINE TITLE

Professionally applied topical fluoride. Evidence-based clinical
recommendations.

#### BIBLIOGRAPHIC SOURCE(S)

American Dental Association Council on Scientific Affairs.
Professionally applied topical fluoride: evidence-based clinical
recommendations. J Am Dent Assoc 2006 Aug;137(8):1151-9. \[45
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16873333)

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Dental caries

#### GUIDELINE CATEGORY

Prevention\
Risk Assessment

#### CLINICAL SPECIALTY

Dentistry

#### INTENDED USERS

Dentists

#### GUIDELINE OBJECTIVE(S)

-   To review the scientific evidence and to develop recommendations for
    the application of topical fluorides for the primary prevention of
    dental caries

-   To serve as an adjunct to the dentist\'s professional judgment of
    how to best utilize professionally applied topical fluoride for each
    individual patient

#### TARGET POPULATION

U.S. population of all ages with natural teeth

#### INTERVENTIONS AND PRACTICES CONSIDERED

Professional application of topical fluoride (sodium fluoride or
acidulated phosphate fluoride) as a gel, foam, or varnish

#### MAJOR OUTCOMES CONSIDERED

Incidence of dental caries

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

MEDLINE and the Cochrane Database of Systematic Reviews were searched
for systematic reviews published in English regarding professionally
applied topical fluoride---including gel, foam and varnish
forms---through October 2005. The \"Find Systematic Reviews\" tool of
the PubMed Clinical Queries search engine
([www.ncbi.nlm.nih.gov/entrez/query/static/clinical.shtml#reviews](http://www.ncbi.nlm.nih.gov/entrez/query/static/clinical.shtml#reviews))
was used. Search terms were fluoride OR APF OR \"acidulated phosphate
fluoride\" OR \"sodium fluoride\" OR \"fluoride gel\" OR \"fluoride
foam.\" Seventeen systematic reviews were identified. The Cochrane Oral
Health Group list of systematic reviews
([www.update-software.com/abstracts/ORALAbstractIndex.htm](http://www.update-software.com/abstracts/ORALAbstractIndex.htm))
was searched manually for additional systematic reviews. Clinical
studies published after January 2004 and, thus, not included in the
systematic reviews also were identified through MEDLINE using the same
search terms. The American Dental Association Council on Scientific
Affairs formed a panel of experts to evaluate the identified systematic
reviews and clinical trials. The expert panelists, listed in the section
\"Composition of Group that Authored the Guideline,\" were provided with
the identified publications and asked to identify any additional
systematic reviews or other relevant published trials. One publication
had been accepted for publication by the Journal of Dental Research and
was included for consideration by the panelists.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### 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

**Levels 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

**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 BMJ Publishing Group from Shekelle and
colleagues. (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

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

The panel graded the evidence on the effectiveness of professionally
applied topical fluoride for the prevention of caries on the basis of
the system of Shekelle and colleagues. (see \"Rating Scheme for the
Strength of the Evidence\").

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The expert panel assessed the data from the individual studies that were
summarized in the systematic reviews and from the identified clinical
studies and convened at a workshop held at the American Dental
Association (ADA) Headquarters in Chicago Oct. 17-18, 2005, to evaluate
the collective evidence and develop evidence-based clinical
recommendations on professionally applied topical fluoride. The panel
classified the strength of the recommendations on professionally applied
topical fluoride on the basis of the system of Shekelle and colleagues
(see \"Rating Scheme for the Strength of the Recommendations\").

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

**Grading 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 BMJ Publishing Group from Shekelle and
colleagues. (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

The product of the workshop was the guideline document, which was
submitted for review to scientists with expertise in fluoride and
caries, relevant American Dental Association (ADA) agencies, and the
external reviewers listed in the acknowledgments in the original
guideline document. The comments received were considered by the expert
panel. The clinical recommendations were approved by the ADA Council on
Scientific Affairs.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Levels of evidence (Ia-IV) and grades of recommendation (A-D) are
defined at the end of the \"Major Recommendations\" field.

The panel encourages dentists to employ caries risk assessment
strategies in their practices. Appropriate preventive dental treatment
(including topical fluoride therapy) can be planned after identification
of caries risk status (see table below). It also is important to
consider that risk of developing dental caries exists on a continuum and
changes over time as risk factors change. Therefore, caries risk status
should be re-evaluated periodically.

+-----------------------------------------------------------------------+
| **Table: Caries Risk Criteria**                                       |
+=======================================================================+
| Patients should be evaluated using caries risk criteria such as those |
| below.                                                                |
|                                                                       |
| **LOW CARIES RISK**                                                   |
|                                                                       |
| **All age groups**                                                    |
|                                                                       |
| No incipient or cavitated primary or secondary carious lesions during |
| the last three years and no factors that may increase caries risk\*   |
|                                                                       |
| **MODERATE CARIES RISK**                                              |
|                                                                       |
| **Younger than 6 years**                                              |
|                                                                       |
| No incipient or cavitated primary or secondary carious lesions during |
| the last three years but presence of at least one factor that may     |
| increase caries risk\*                                                |
|                                                                       |
| **Older than 6 years (any of the following)**                         |
|                                                                       |
| -   One or two incipient or cavitated primary or secondary carious    |
|     lesions in the last three years                                   |
|                                                                       |
| -   No incipient or cavitated primary or secondary carious lesions in |
|     the last three years but presence of at least one factor that may |
|     increase caries risk\*                                            |
|                                                                       |
| **HIGH CARIES RISK**                                                  |
|                                                                       |
| **Younger than 6 years (any of the following)**                       |
|                                                                       |
| -   Any incipient or cavitated primary or secondary carious lesion    |
|     during the last three years                                       |
|                                                                       |
| -   Presence of multiple factors that may increase caries risk\*      |
|                                                                       |
| -   Low socioeconomic status\*\*                                      |
|                                                                       |
| -   Suboptimal fluoride exposure                                      |
|                                                                       |
| -   Xerostomia\*\*\*                                                  |
|                                                                       |
| **Older than 6 years (any of the following)**                         |
|                                                                       |
| -   Three or more incipient or cavitated primary or secondary carious |
|     lesions in the last three years                                   |
|                                                                       |
| -   Presence of multiple factors that may increase caries risk\*      |
|                                                                       |
| -   Suboptimal fluoride exposure                                      |
|                                                                       |
| -   Xerostomia\*\*\*                                                  |
+-----------------------------------------------------------------------+
| \* Factors increasing risk of developing caries also may include, but |
| are not limited to, high titers of cariogenic bacteria, poor oral     |
| hygiene, prolonged nursing (bottle or breast), poor family dental     |
| health, developmental or acquired enamel defects, genetic abnormality |
| of teeth, many multisurface restorations, chemotherapy or radiation   |
| therapy, eating disorders, drug or alcohol abuse, irregular dental    |
| care, cariogenic diet, active orthodontic treatment, presence of      |
| exposed root surfaces, restoration overhangs and open margins, and    |
| physical or mental disability with inability or unavailability of     |
| performing proper oral health care.                                   |
|                                                                       |
| \*\* On the basis of findings from population studies, groups with    |
| low socioeconomic status have been found to have an increased risk of |
| developing caries. In children too young for their risk to be based   |
| on caries history, low socioeconomic status should be considered as a |
| caries risk factor.                                                   |
|                                                                       |
| \*\*\* Medication-, radiation- or disease-induced xerostomia.         |
+-----------------------------------------------------------------------+

The table below summarizes the evidence-based clinical recommendations
for the use of professionally applied topical fluoride. The clinical
recommendations are a resource for dentists to use. These clinical
recommendations must be balanced with the practitioner\'s professional
judgment and the individual patient\'s preferences.

It is recommended that all age and risk groups use an appropriate amount
of fluoride toothpaste when brushing twice a day, and that the amount of
toothpaste used for children younger than 6 years not exceed the size of
a pea. For patients at moderate and high risk of caries, additional
preventive interventions should be considered, including use of
additional fluoride products at home, pit-and-fissure sealants, and
antibacterial therapy.

  --------------------------------------------------------------------------------
  **Table:                                                    
  Evidence-based                                              
  Clinical                                                    
  Recommendations                                             
  for                                                         
  Professionally                                              
  Applied Topical                                             
  Fluoride**                                                  
  ----------------- ---------------------------- ------------ --------------------
  **Risk Category** **AGE CATEGORY FOR RECALL                 
                    PATIENTS**                                

  ** **             **\< 6 Years**                            

                    **Recommendation**           **Grade of   **Strength of
                                                 Evidence**   Recommendation**

  **Low**           May not receive additional   Ia           B
                    benefit from professional                 
                    topical fluoride                          
                    application\*                             

  **Moderate**      Varnish application at       Ia           A
                    6-month intervals                         

  **High**          Varnish application at       Ia           A
                    6-month intervals                         

                    OR                           ** **        ** **

                    Varnish application at       Ia           D\*\*
                    3-month intervals                         

                    **6 to 18 Years**                         

                    **Recommendation**           **Grade of   **Strength of
                                                 Evidence**   Recommendation**

  **Low**           May not receive additional   Ia           B
                    benefit from professional                 
                    topical fluoride                          
                    application\*                             

  **Moderate**      Varnish application at       Ia           A
                    6-month intervals                         

                    OR                           ** **        ** **

                    Fluoride gel application at  Ia           A
                    6-month intervals                         

  **High**          Varnish application at       Ia           A
                    6-month intervals                         

                    OR                           ** **        ** **

                    Varnish application at       Ia           A\*\*
                    3-month intervals                         

                    OR                           ** **        ** **

                    Fluoride gel application at  Ia           A
                    6-month intervals                         

                    OR                           ** **        ** **

                    Fluoride gel application at  IV           D\*\*\*
                    3-month intervals                         

                    **18 + Years**                            

                    **Recommendation**           **Grade of   **Strength of
                                                 Evidence**   Recommendation**

  **Low**           May not receive additional   IV           D
                    benefit from professional                 
                    topical fluoride                          
                    application\*                             

  **Moderate**      Varnish application at       IV           D#
                    6-month intervals                         

                    OR                           ** **        ** **

                    Fluoride gel application at  IV           D\*\*\*
                    6-month intervals                         

  **High**          Varnish application at       IV           D#
                    6-month intervals                         

                    OR                           ** **        ** **

                    Varnish application at       IV           D#
                    3-month intervals                         

                    OR                           ** **        ** **

                    Fluoride gel application at  IV           D\*\*\*
                    6-month intervals                         

                    OR                           ** **        ** **

                    Fluoride gel application at  IV           D\*\*\*
                    3-month intervals                         

  \* Fluoridated                                              
  water and                                                   
  fluoride                                                    
  toothpastes may                                             
  provide adequate                                            
  caries prevention                                           
  in this risk                                                
  category. Whether                                           
  or not to apply                                             
  topical fluoride                                            
  in such cases is                                            
  a decision that                                             
  should balance                                              
  this                                                        
  consideration                                               
  with the                                                    
  practitioner\'s                                             
  professional                                                
  judgment and the                                            
  individual                                                  
  patient\'s                                                  
  preferences.\                                               
  \                                                           
  \*\* Emerging                                               
  evidence                                                    
  indicates that                                              
  applications more                                           
  frequent than                                               
  twice per year                                              
  may be more                                                 
  effective in                                                
  preventing                                                  
  caries.\                                                    
  \                                                           
  \*\*\* Although                                             
  there are no                                                
  clinical trials,                                            
  there is reason                                             
  to believe that                                             
  fluoride gels                                               
  would work                                                  
  similarly in this                                           
  age group.\                                                 
  \                                                           
  \# Although there                                           
  are no clinical                                             
  trials, there is                                            
  reason to believe                                           
  that fluoride                                               
  varnish would                                               
  work similarly in                                           
  this age group.\                                            
  \                                                           
  Laboratory data                                             
  demonstrate                                                 
  foam\'s                                                     
  equivalence to                                              
  gels in terms of                                            
  fluoride release;                                           
  however, only two                                           
  clinical trials                                             
  have been                                                   
  published                                                   
  evaluating its                                              
  effectiveness.                                              
  Because of this,                                            
  the                                                         
  recommendations                                             
  for use of                                                  
  fluoride varnish                                            
  and gel have not                                            
  been extrapolated                                           
  to foams.\                                                  
  \                                                           
  Because there is                                            
  insufficient                                                
  evidence to                                                 
  address whether                                             
  or not there is a                                           
  difference in the                                           
  efficacy of                                                 
  sodium fluoride                                             
  versus acidulated                                           
  phosphate                                                   
  fluoride gels,                                              
  the clinical                                                
  recommendations                                             
  do not specify                                              
  between these two                                           
  formulations of                                             
  fluoride gels.                                              
  Application time                                            
  for fluoride gel                                            
  and foam should                                             
  be four minutes.                                            
  A one-minute                                                
  fluoride                                                    
  application is                                              
  not endorsed.                                               
  --------------------------------------------------------------------------------

**[Definitions]{.underline}**:

**Levels 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

**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 BMJ Publishing Group from Shekelle and
colleagues. (Shekelle PG, Woolf SH, Eccles M, Grimshaw J. Clinical
guidelines: developing guidelines. Brit Med J 1999;318(7183):593-6.

**Grading 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 BMJ Publishing Group from Shekelle and
colleagues. (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 Major recommendations\").

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate use of professionally-applied topical fluoride for
prevention of dental caries

#### POTENTIAL HARMS

Not stated

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

These recommendations are offered with the understanding that the
dentist, knowing the patient\'s health history and vulnerability to oral
disease, is in the best position to make treatment recommendations in
the interest of each patient. For this reason, evidence-based clinical
recommendations are intended to provide guidance, and are not a standard
of care, requirements or regulations. The clinical recommendations are a
resource for dentists to use. These clinical recommendations must be
balanced with the practitioner\'s professional judgment and the
individual patient\'s preferences.

### 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](#identifying-information-and-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

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

American Dental Association Council on Scientific Affairs.
Professionally applied topical fluoride: evidence-based clinical
recommendations. J Am Dent Assoc 2006 Aug;137(8):1151-9. \[45
references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16873333)

#### ADAPTATION

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

#### DATE RELEASED

2006 Aug

#### GUIDELINE DEVELOPER(S)

American Dental Association - Professional Association

#### SOURCE(S) OF FUNDING

American Dental Association

#### GUIDELINE COMMITTEE

Expert Panel on Professionally Applied Topical Fluoride

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Panel Members*: Jeffrey W. Hutter, DMD, Med (*Chairman*) Goldman School
of Dental Medicine, Boston University, Boston; Jarvis T. Chan, PhD, DDS,
The University of Texas Health Science Center---Houston, Medical School;
John D.B. Featherstone, MSc, PhD, University of California, San
Francisco; Amid Ismail, BDS, MPH, MBA, DrPH, University of Michigan,
School of Dentistry, Ann Arbor; Albert Kingman, PhD, National Institute
of Dental and Craniofacial Research, National Institutes of Health,
Bethesda, Md.; John Stamm, MScD, DDPH, DDS, School of Dentistry, The
University of North Carolina at Chapel Hill; Norman Tinanoff, DDS, MS,
University of Maryland, Baltimore College of Dental Surgery; James S.
Wefel, PhD, The University of Iowa College of Dentistry, Iowa City;
Domenick T. Zero, DDS, MS, Indiana University School of Dentistry,
Indianapolis

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Panelists were selected on the basis of their expertise in the relevant
subject matter. They were required to sign a disclosure stating that
neither they nor their spouse or dependent children had a significant
financial interest that would reasonably appear to affect the
development of these recommendations.

#### 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](http://www.ada.org/prof/resources/pubs/jada/reports/report_fluoride.pdf).

Print copies: Available from the American Dental Association Council on
Scientific Affairs, 211 E. Chicago Ave., Chicago, Ill. 60611.

#### AVAILABILITY OF COMPANION DOCUMENTS

The following is available:

-   American Dental Association Council on Scientific Affairs.
    Professionally applied topical fluoride: executive summary of
    evidence-based clinical recommendations. Chicago (IL): American
    Dental Assocation; 2006. 4 p.

Electronic copies: Available in Portable Document Format (PDF) from the
[American Dental Association Web
site](http://www.ada.org/prof/resources/pubs/jada/reports/report_fluoride_exec.pdf).

#### PATIENT RESOURCES

The following is available:

-   Fluoride treatments in the dental office: extra protection for your
    teeth. J Am Dent Assoc. 2007 Mar;138(3):420.

Electronic copies: Available in Portable Document Format (PDF) from the
[American Dental Association Web
site](http://www.ada.org/prof/resources/pubs/jada/patient.asp).

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 on February 9, 2007. The
information was verified by the guideline developer on February 20,
2007.

#### 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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Date Modified: 11/3/2008