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Caries Management by Risk Assessment in Children

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01310283
Recruitment Status : Completed
First Posted : March 8, 2011
Last Update Posted : November 14, 2012
Sponsor:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment
Dental Caries Other: xylitol mints and fluoride varnish

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Caries Management by Risk Assessment in Children
Study Start Date : April 2010
Primary Completion Date : May 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. new decayed surfaces [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. cariogenic bacteria levels [ Time Frame: 6 month and 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   5 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: March 8, 2011    Key Record Dates
Last Update Posted: November 14, 2012
Last Verified: November 2012

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

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Fluorides
Fluorides, Topical
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs