Dental CariesPhase 3NCT00066963
Fluoride Varnish Randomized Clinical Trial
A Phase 3 study testing Fluoride Varnish in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
Trial summary
The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five). Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Fluoride Varnish
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 376 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2002to Dec 2006
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children < 44 months old
- Caries-free
- 4 erupted maxillary incisors
- Residing in fluoridated community (San Francisco)
Who cannot join
- Cleft Palate
- Developmental or learning disabilities
- Children with transient residence (homeless, migrant, foster home)
- Children with an another household member participating in the study
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF School of Dentistry
San Francisco, California, 94143-1361
About this study
Official title: Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes
The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).
Read the detailed description
This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.
- Conditions
- Dental Caries
- Being tested
- Fluoride Varnish
- Keywords
- Early Childhood Caries
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride VarnishDevice
Also called Duraphat® (Colgate Oral Pharmaceuticals)
0.1 mL (1 drop) applied on each of 2 arches
| Study group | Role | What they receive |
|---|---|---|
| Counseling Only | No intervention | Counseling Only |
| FV every 12mo for 24mo + Counsel | Experimental | Preventive fluoride varnish every 12mo for 24mo plus Counseling Receives: Device: Fluoride Varnish |
| FV every 6mo for 24mo + Counseling | Experimental | Preventive fluoride varnish every 6mo for 24mo plus Counseling Receives: Device: Fluoride Varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Caries Incident Cases
A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2003 (estimated)
- Study startOct 2002
- Primary completionNov 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 376 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jane A Weintraub, DDS, MPH, Principal investigator, University of California, San Francisco (now Univ North Carolina)Francisco Ramos-Gomez, DDS, MPH, Study director, University of California, San Francisco (now Univ Calif Los Angeles)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00066963
- Sponsor's protocol ID
- NIDCR-13058
- Status last verified
- Mar 2022
- First submitted
- 7 Aug 2003
- Last updated
- 9 Mar 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD, Gansky SA. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6. doi: 10.1177/154405910608500211.
PubMed 16434737Gansky SA, Cheng NF, Koch GG. Dose-Weighted Adjusted Mantel-Haenszel Tests for Numeric Scaled Strata in a Randomized Trial. Stat Biopharm Res. 2011 May 1;3(2):266-275. doi: 10.1198/sbr.2011.10014.
PubMed 21709814Lazar AA, Gansky SA, Halstead DD, Slajs A, Weintraub JA. Improving Patient Care Using the Johnson-Neyman Analysis of Heterogeneity of Treatment Effects According to Individuals' Baseline Characteristics. J Dent Oral Craniofac Epidemiol. 2013 Oct 1;1(3):19-33.
PubMed 25705704
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes
- ClinicalTrials.gov ID
- NCT00066963
- Acronym / sponsor ID
- NIDCR-13058
- Conditions
- Dental Caries
- Keywords
- Early Childhood Caries
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 376 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2002
- Primary completion
- Nov 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 8 Aug 2003 (estimated)
- Results
- Posted 8 May 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the efficacy of fluoride varnish (FV) applied once or twice a year with counseling to counseling alone in preventing early childhood caries (ECC) (tooth decay in children under the age of five).
Detailed description
This project was a prospective, randomized clinical trial (RCT) among initially caries-free children from about six months old (when primary teeth erupt) up to age three at two public health facilities in San Francisco, one serving a primarily Latino and one a primarily Asian population. The RCT 1) Compared the efficacy of once or twice/year fluoride varnish (FV) application and counseling to counseling alone in preventing early childhood caries (ECC); 2) Assessed pre-intervention salivary markers (biologic and chemical), behavioral and demographic factors as predictors of ECC; 3) Compared the efficacy of these interventions between sites serving different ethnic populations with a high prevalence of ECC; and 4) Determined the salivary fluoride release profile following exposure to fluoride varnish.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Counseling Only | No intervention | –Counseling Only |
| FV every 12mo for 24mo + Counsel | Experimental | Device: Fluoride VarnishPreventive fluoride varnish every 12mo for 24mo plus Counseling |
| FV every 6mo for 24mo + Counseling | Experimental | Device: Fluoride VarnishPreventive fluoride varnish every 6mo for 24mo plus Counseling |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children < 44 months old
- Caries-free
- 4 erupted maxillary incisors
- Residing in fluoridated community (San Francisco)
Key exclusion criteria (4 listed)
- Cleft Palate
- Developmental or learning disabilities
- Children with transient residence (homeless, migrant, foster home)
- Children with an another household member participating in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride VarnishAlso: Duraphat® (Colgate Oral Pharmaceuticals)0.1 mL (1 drop) applied on each of 2 arches | Device | FV every 12mo for 24mo + Counsel, FV every 6mo for 24mo + Counseling |
Primary outcome
Number of Caries Incident Cases
Time frame: two years
A trained, calibrated dentist blinded to treatment arm performed visual-tactile dental exams at 1 and 2 years post-baseline. Group-specific number of incident cases were reported as the number of individual participants with caries at a follow-up visit.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16434737Weintraub JA, Ramos-Gomez F, Jue B, Shain S, Hoover CI, Featherstone JD, Gansky SA. Fluoride varnish efficacy in preventing early childhood caries. J Dent Res. 2006 Feb;85(2):172-6. doi: 10.1177/154405910608500211.
- Results publication: PubMed 21709814Gansky SA, Cheng NF, Koch GG. Dose-Weighted Adjusted Mantel-Haenszel Tests for Numeric Scaled Strata in a Randomized Trial. Stat Biopharm Res. 2011 May 1;3(2):266-275. doi: 10.1198/sbr.2011.10014.
- Results publication: PubMed 25705704Lazar AA, Gansky SA, Halstead DD, Slajs A, Weintraub JA. Improving Patient Care Using the Johnson-Neyman Analysis of Heterogeneity of Treatment Effects According to Individuals' Baseline Characteristics. J Dent Oral Craniofac Epidemiol. 2013 Oct 1;1(3):19-33.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jane A Weintraub, DDS, MPH principal investigator
University of California, San Francisco (now Univ North Carolina)
Francisco Ramos-Gomez, DDS, MPH study director
University of California, San Francisco (now Univ Calif Los Angeles)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluoride Varnish in people with Dental Caries, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 May 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Caries Incident Cases (time frame: two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00066963, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2022.