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Completed

NCT Number: NCT00066963

Fluoride Varnish Randomized Clinical Trial

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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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

6 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

UCSF School of Dentistry

San Francisco, California, 94143-1361, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fluoride varnish

Device

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

Other names: Duraphat® (Colgate Oral Pharmaceuticals)

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Official study title

Comprehensive Oral Health Center for Discovery: New Strategies for Enhancing Tissue Integrity and Repair Early Childhood Caries: Prevention and Treatment Outcomes

Important dates

Study start
2002
Primary completion
2006
Study completion
2006
First posted
Aug 8, 2003
Registry last updated
Mar 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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