Caries Management by Risk Assessment in Children

University of California San Francisco (UCSF)

Status: Completed

Conditions: Dental Caries

Treatments: Other: xylitol mints and fluoride varnish

Study type: Interventional

Funder types: Other

Identifiers

NCT01310283

A106017

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 5 to 9 years old

Volunteers: Accepts Healthy Volunteers

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

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

120 participants in 1 patient group

control group

No Intervention group

Description:

Conventional pediatric dental care.

Treatment:

Other: xylitol mints and fluoride varnish