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Caries Management by Risk Assessment in Children

NCT ID: NCT01310283

Last Updated: 2012-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2012-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Dental Caries

Keywords

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dental caries children mutans streptococci lactobacilli cariogenic bacteria

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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control group

Conventional pediatric dental care.

Group Type NO_INTERVENTION

xylitol mints and fluoride varnish

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

5 Years

Maximum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Ling Zhan

Asisstant professor in residence

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ling Zhan, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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

San Francisco, California, United States

Site Status

The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School

San Francisco, California, United States

Site Status

Countries

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United States

Other Identifiers

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A106017

Identifier Type: -

Identifier Source: org_study_id