Caries Management by Risk Assessment in Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ling Zhan, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01310283
First received: March 4, 2011
Last updated: November 9, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
Dental Caries
Other: xylitol mints and fluoride varnish

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Caries Management by Risk Assessment in Children

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • new decayed surfaces [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • cariogenic bacteria levels [ Time Frame: 6 month and 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: April 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: control group
Conventional pediatric dental care.
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.

  Eligibility

Ages Eligible for Study:   5 Years to 9 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01310283

Locations
United States, California
Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School
San Francisco, California, United States, 94143
The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Ling Zhan, DDS, PhD University of California, San Francisco
  More Information

No publications provided

Responsible Party: Ling Zhan, Asisstant professor in residence, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01310283     History of Changes
Other Study ID Numbers: A106017
Study First Received: March 4, 2011
Last Updated: November 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
dental caries
children
mutans streptococci
lactobacilli
cariogenic bacteria

Additional relevant MeSH terms:
Dental Caries
Stomatognathic Diseases
Tooth Demineralization
Tooth Diseases

ClinicalTrials.gov processed this record on October 22, 2014