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OpenTrials
Completed

NCT Number: NCT01310283

Caries Management by Risk Assessment in Children

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.

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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

5 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School, San Francisco, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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
  • 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

Treatment and study plan

xylitol mints and fluoride varnish

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.

Primary outcomes

  1. new decayed surfaces

    Time frame: 1 year

Secondary outcomes

  1. cariogenic bacteria levels

    Time frame: 6 month and 1 year

Sponsors and collaborators

Lead sponsor

University of California, San Francisco

Other

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Mar 8, 2011
Registry last updated
Nov 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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