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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Counseling Only | No Intervention | Counseling Only | |
| FV every 12mo for 24mo + Counsel | Experimental | Preventive fluoride varnish every 12mo for 24mo plus Counseling |
|
| FV every 6mo for 24mo + Counseling | Experimental | Preventive fluoride varnish every 6mo for 24mo plus Counseling |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoride Varnish | Device | 0.1 mL (1 drop) applied on each of 2 arches |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | two years |
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Inclusion
Exclusion
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| Name | Affiliation | Role |
|---|---|---|
| Jane A Weintraub, DDS, MPH | University of California, San Francisco (now Univ North Carolina) | Principal Investigator |
| Francisco Ramos-Gomez, DDS, MPH | University of California, San Francisco (now Univ Calif Los Angeles) | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UCSF School of Dentistry | San Francisco | California | 94143-1361 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16434737 | Result | 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. | |
| 21709814 | Result | Gansky 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. |
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Cleft lip or palate, developmental or learning disabilities, older than 36 mos; younger than 6 mos,immuno-compromised, born outside SF Bay Area where water is non-fluoridated, lack parental consent; lack 4 maxillary incisors, have caries, other family member in study, transient parents, ineligible to use SF Health Dept service
January 2001 - July 2002. Supplemental Nutrition Program for Women, Infants & Children (WICs); Womens resource center; medical clinics; pre-schools; dental clinics
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| ID | Title | Description |
|---|---|---|
| FG000 | No Intervention: Counseling Only | Counseling Only (0FV) |
| FG001 | Experimental: FV Every 12mo for 24mo + Counsel | Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV) |
| FG002 | Experimental: FV Every 6mo for 24mo + Counsel | Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | No Intervention: Counseling Only | Counseling Only (0FV) |
| BG001 | Experimental: FV Every 12mo for 24mo + Counsel | Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV) |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses. | Posted | Number | participants | two years |
|
3 years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | No Intervention: Counseling Only | Counseling Only (0FV) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Ulcer on the cheek | Skin and subcutaneous tissue disorders | Systematic Assessment | Upon questioning, a parent reported at the 18-month visit the child had an "ulcer on the cheek" onsetting 2 months after the last fluoride varnish application, which was a "fluoride-free" placebo application. The ulcer was gone at the 24-month visit. |
In a protocol deviation, children received placebo varnish for 10 months; this would be expected to bias the study toward the null of no difference among groups. The study did not address FV efficacy for children with extant or past caries.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stuart Gansky | Professor, S/D- PREV/REST | 415-502-8094 | stuart.gansky@ucsf.edu |
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| ID | Term |
|---|---|
| D003731 | Dental Caries |
| ID | Term |
|---|---|
| D017001 | Tooth Demineralization |
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
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| 25705704 | Result | Lazar 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. |
| BG002 | Experimental: FV Every 6mo for 24mo + Counsel | Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV) |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | Year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG002 | FV 2x/Year + Counseling | fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months) |
|
|
|
| 0 |
| 100 |
| 0 |
| 100 |
| EG001 | Experimental: FV Every 12mo for 24mo + Counsel | Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV) | 0 | 93 | 0 | 93 |
| EG002 | Experimental: FV Every 6mo for 24mo + Counsel | Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV) | 0 | 87 | 1 | 87 |
|
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