Caries Management by Risk Assessment in Children

University of California, San Francisco120 enrolled

Overview

The goal of this study is to address the effectiveness of a modified cavity prevention protocol for 5-9 year-old children which emphasizes better diet modification, more frequent professional fluoride applications, and xylitol product usage based on individual risk status in a 1-year randomized controlled clinical trial in the University of California, San Francisco (UCSF) Tenderloin Community Pediatric Dental Clinic. The investigators hypothesize that the regimen will help to reduce new cavities in children who are at risk for dental cavities.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Enrollment

120

Conditions

Dental Caries

Interventions

xylitol mints and fluoride varnishOTHER

Subjects in the intervention group will receive additional diet, oral hygiene handouts, more frequent professional fluoride application, and xylitol mints based on their caries risk levels.

Eligibility

Sex: ALLMin age: 5 YearsMax age: 9 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be: 2. Patients of record at the Tenderloin community and UCSF pediatric dental clinics 3. 5-9 years old 3\. Be able to give informed assent, consent and answer questionnaires in English, Spanish or Chinese by parents or guardian 4. Be unlikely to move from the area during the study period 5. Be willing to participate regardless of group assignment and comply with all study procedures Exclusion Criteria: Persons with: 1. Prolonged antibiotic use in the past three months. 2. Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics

Locations (2)

Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School

San Francisco, California, United States

The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School

San Francisco, California, United States

Outcomes

Primary Outcomes

new decayed surfaces

Time frame: 1 year

Secondary Outcomes

cariogenic bacteria levels

Time frame: 6 month and 1 year

Data from ClinicalTrials.gov

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