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Caries Management by Risk Assessment in Children

Primary Purpose

Dental Caries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
xylitol mints and fluoride varnish
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries focused on measuring dental caries, children, mutans streptococci, lactobacilli, cariogenic bacteria

Eligibility Criteria

5 Years - 9 Years (Child)All SexesAccepts 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

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

Sites / Locations

  • Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School
  • The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

control group

Arm Description

Conventional pediatric dental care.

Outcomes

Primary Outcome Measures

new decayed surfaces

Secondary Outcome Measures

cariogenic bacteria levels

Full Information

First Posted
March 4, 2011
Last Updated
November 9, 2012
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT01310283
Brief Title
Caries Management by Risk Assessment in Children
Official Title
Caries Management by Risk Assessment in Children
Study Type
Interventional

2. Study Status

Record Verification Date
November 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
Keywords
dental caries, children, mutans streptococci, lactobacilli, cariogenic bacteria

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
control group
Arm Type
No Intervention
Arm Description
Conventional pediatric dental care.
Intervention Type
Other
Intervention Name(s)
xylitol mints and fluoride varnish
Intervention Description
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.
Primary Outcome Measure Information:
Title
new decayed surfaces
Time Frame
1 year
Secondary Outcome Measure Information:
Title
cariogenic bacteria levels
Time Frame
6 month and 1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients of record at the UCSF Pediatric Dental Clinic, or the UCSF Tenderloin Community Pediatric Dental Clinic, and must be: Patients of record at the Tenderloin community and UCSF pediatric dental clinics 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: Prolonged antibiotic use in the past three months. Dental needs outside of the community pediatric clinics, such as care provided in specialty clinics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ling Zhan, DDS, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States

12. IPD Sharing Statement

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Caries Management by Risk Assessment in Children

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