Caries Management by Risk Assessment in Children

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01310283

Enrollment

120

Registered

2011-03-08

Start date

2010-04-30

Completion date

2012-05-31

Last updated

2012-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Caries

Keywords

dental caries, children, mutans streptococci, lactobacilli, cariogenic bacteria

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.

Interventions

OTHERxylitol 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

5 Years to 9 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
new decayed surfaces	1 year

Secondary

Measure	Time frame
cariogenic bacteria levels	6 month and 1 year

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026