Caries Management by Risk Assessment in Children
1 other identifier
interventional
120
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2010
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2011
CompletedFirst Posted
Study publicly available on registry
March 8, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedNovember 14, 2012
November 1, 2012
2.1 years
March 4, 2011
November 9, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
new decayed surfaces
1 year
Secondary Outcomes (1)
cariogenic bacteria levels
6 month and 1 year
Study Arms (1)
control group
NO INTERVENTIONConventional pediatric dental care.
Interventions
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 Criteria
You may qualify if:
- 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
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Pediatric Dental Clinic at UCSF, School of Dentistry and UCSF Pediatric Dentistry Clinica at the Tenderloin Community School
San Francisco, California, 94143, United States
The Pediatric Dentistry Clinic at UCSF and Tenderloin Community Elementary School
San Francisco, California, 94143, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ling Zhan, DDS, PhD
University of California, San Francisco
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Asisstant professor in residence
Study Record Dates
First Submitted
March 4, 2011
First Posted
March 8, 2011
Study Start
April 1, 2010
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
November 14, 2012
Record last verified: 2012-11