Dental Caries
Conditions
Keywords
Early Childhood Caries
Brief 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).
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.
Interventions
DEVICEFluoride Varnish
0.1 mL (1 drop) applied on each of 2 arches
Sponsors
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
6 Months to 36 Months
Healthy volunteers
Yes
Inclusion criteria
Inclusion * Children \< 44 months old * Caries-free * 4 erupted maxillary incisors * Residing in fluoridated community (San Francisco) Exclusion * Cleft Palate * Developmental or learning disabilities * Children with transient residence (homeless, migrant, foster home) * Children with an another household member participating in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Caries Incident Cases | 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. |
Countries
United States
Participant flow
Recruitment details
January 2001 - July 2002. Supplemental Nutrition Program for Women, Infants & Children (WICs); Womens resource center; medical clinics; pre-schools; dental clinics
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| No Intervention: Counseling Only Counseling Only (0FV) | 126 |
| Experimental: FV Every 12mo for 24mo + Counsel Preventive fluoride varnish every 12mo for 24mo plus Counseling (2FV) | 124 |
| Experimental: FV Every 6mo for 24mo + Counsel Preventive fluoride varnish every 6mo for 24mo plus Counseling (4FV) | 126 |
| Total | 376 |
Baseline characteristics
| Characteristic | Experimental: FV Every 12mo for 24mo + Counsel | Experimental: FV Every 6mo for 24mo + Counsel | No Intervention: Counseling Only | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 124 Participants | 126 Participants | 126 Participants | 376 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 1.8 Year STANDARD_DEVIATION 0.5 | 1.8 Year STANDARD_DEVIATION 0.6 | 1.8 Year STANDARD_DEVIATION 0.6 | 1.8 Year STANDARD_DEVIATION 0.6 |
| Region of Enrollment United States | 124 participants | 126 participants | 126 participants | 376 participants |
| Sex: Female, Male Female | 66 Participants | 64 Participants | 68 Participants | 198 Participants |
| Sex: Female, Male Male | 58 Participants | 62 Participants | 58 Participants | 178 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 100 | 0 / 93 | 1 / 87 |
| serious Total, serious adverse events | 0 / 100 | 0 / 93 | 0 / 87 |
Outcome results
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.
Time frame: two years
Population: intention-to-treat with any follow-up information. multiple imputation for sensitivity analyses.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Counseling Only | Number of Caries Incident Cases | 42 participants |
| FV 1x/Year + Counseling | Number of Caries Incident Cases | 23 participants |
| FV 2x/Year + Counseling | Number of Caries Incident Cases | 14 participants |
Comparison: Planned sample size of 384 participants (128/study arm) (alpha = 0.05, power = 90%, 50% attrition, χ2 test) to detect caries incidence differences, based on caries incidence in the literature (20% to 50% over two years). 50% attrition in the sample size calculation was selected based on the literature (e.g. Weinstein et al., 1994 reported 53% attrition in six months.)p-value: <0.00195% CI: [1.9, 7.6]Mantel Haenszel