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Trial Outcomes & Findings for Fluoride Varnish Randomized Clinical Trial (NCT NCT00066963)

NCT ID: NCT00066963

Last Updated: 2022-03-09

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

376 participants

Primary outcome timeframe

two years

Results posted on

2022-03-09

Participant Flow

January 2001 - July 2002. Supplemental Nutrition Program for Women, Infants \& Children (WICs); Womens resource center; medical clinics; pre-schools; dental clinics

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

Participant milestones

Participant milestones
Measure
No Intervention: Counseling Only
Counseling Only (0FV)
Experimental: FV Every 12mo for 24mo + Counsel
Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
Experimental: FV Every 6mo for 24mo + Counsel
Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
Overall Study
STARTED
126
124
126
Overall Study
COMPLETED
100
93
87
Overall Study
NOT COMPLETED
26
31
39

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Fluoride Varnish Randomized Clinical Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
No Intervention: Counseling Only
n=126 Participants
Counseling Only (0FV)
Experimental: FV Every 12mo for 24mo + Counsel
n=124 Participants
Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
Experimental: FV Every 6mo for 24mo + Counsel
n=126 Participants
Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
Total
n=376 Participants
Total of all reporting groups
Age, Categorical
<=18 years
126 Participants
n=5 Participants
124 Participants
n=7 Participants
126 Participants
n=5 Participants
376 Participants
n=4 Participants
Age, Categorical
Between 18 and 65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Categorical
>=65 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=4 Participants
Age, Continuous
1.8 Year
STANDARD_DEVIATION 0.6 • n=5 Participants
1.8 Year
STANDARD_DEVIATION 0.5 • n=7 Participants
1.8 Year
STANDARD_DEVIATION 0.6 • n=5 Participants
1.8 Year
STANDARD_DEVIATION 0.6 • n=4 Participants
Sex: Female, Male
Female
68 Participants
n=5 Participants
66 Participants
n=7 Participants
64 Participants
n=5 Participants
198 Participants
n=4 Participants
Sex: Female, Male
Male
58 Participants
n=5 Participants
58 Participants
n=7 Participants
62 Participants
n=5 Participants
178 Participants
n=4 Participants
Region of Enrollment
United States
126 participants
n=5 Participants
124 participants
n=7 Participants
126 participants
n=5 Participants
376 participants
n=4 Participants

PRIMARY outcome

Timeframe: two years

Population: intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.

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.

Outcome measures

Outcome measures
Measure
Counseling Only
n=100 Participants
caregiver counseling only (zero fluoride varnish)
FV 1x/Year + Counseling
n=93 Participants
fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) once per year for 2 years (every 12 months) plus caregiver counseling
FV 2x/Year + Counseling
n=87 Participants
fluoride varnish (FV) (5% NaF, Duraphat®, Colgate) twice per year for 2 years (every 6 months)
Number of Caries Incident Cases
42 participants
23 participants
14 participants

Adverse Events

No Intervention: Counseling Only

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental: FV Every 12mo for 24mo + Counsel

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Experimental: FV Every 6mo for 24mo + Counsel

Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
No Intervention: Counseling Only
n=100 participants at risk
Counseling Only (0FV)
Experimental: FV Every 12mo for 24mo + Counsel
n=93 participants at risk
Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV)
Experimental: FV Every 6mo for 24mo + Counsel
n=87 participants at risk
Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV)
Skin and subcutaneous tissue disorders
Ulcer on the cheek
0.00%
0/100 • 3 years
0.00%
0/93 • 3 years
1.1%
1/87 • Number of events 1 • 3 years

Additional Information

Stuart Gansky

Professor, S/D- PREV/REST

Phone: 415-502-8094

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place