Caries Management by Risk Assessment in Children

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Other: xylitol mints and fluoride varnish

• Registration Number: NCT01310283
• Lead Sponsor: University of California, San Francisco

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2011-03-04
• Study First Submitted QC: 2011-03-07
• Study First Posted: 2011-03-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-09
• Last Update Posted: 2012-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

4. 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	xylitol mints and fluoride varnish	Conventional pediatric dental care.

Primary Outcome Measures

Name	Time	Method
new decayed surfaces	1 year

Secondary Outcome Measures

Name	Time	Method
cariogenic bacteria levels	6 month and 1 year

Trial Locations

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