Fluoride Varnish Randomized Clinical Trial

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

376 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2006-12-31

Brief Summary

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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).

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Detailed Description

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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

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Counseling Only

Group Type NO_INTERVENTION

No interventions assigned to this group

FV every 12mo for 24mo + Counsel

Preventive fluoride varnish every 12mo for 24mo plus Counseling

Group Type EXPERIMENTAL

Fluoride Varnish

Intervention Type DEVICE

0.1 mL (1 drop) applied on each of 2 arches

FV every 6mo for 24mo + Counseling

Preventive fluoride varnish every 6mo for 24mo plus Counseling

Group Type EXPERIMENTAL

Fluoride Varnish

Intervention Type DEVICE

0.1 mL (1 drop) applied on each of 2 arches

Interventions

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Fluoride Varnish

0.1 mL (1 drop) applied on each of 2 arches

Intervention Type DEVICE

Other Intervention Names

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Duraphat® (Colgate Oral Pharmaceuticals)

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

6 Months

Maximum Eligible Age

36 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes