Caries Management by Risk Assessment in Children

Dental Caries Clinical Trial

Official title:

Caries Management by Risk Assessment in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01310283
• Other study ID #: A106017
• Status: Completed
• Phase: N/A
• First received: March 4, 2011
• Last updated: November 9, 2012
• Start date: April 2010
• Est. completion date: May 2012

Study information

• Verified date: November 2012
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 5 Years to 9 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Dental Caries

Intervention

Other:
• xylitol mints and fluoride varnish
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.

Locations

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	new decayed surfaces		1 year	No
Secondary	cariogenic bacteria levels		6 month and 1 year	No