CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network

Completed · Not applicable · Has a placebo group

Conditions studied: Dental Caries

In brief

The goal of this project is to create a Practice Based Research Network with 30 researcher dentists calibrated on the administration of a caries risk assessment and the treatment modalities recommended based on the caries risk assessment results (Caries Management by Risk Assessment - CAMBRA), and to conduct a 2-year CAMBRA study in those dental offices. Participating dentists will be a mix of general practitioners and pediatric dentists selected from private practice, part time university faculty, large group practices, or community clinics. Participating practices will collect baseline data and patient progress and report on patient acceptance and compliance, and the effectiveness of treatment. The program's duration is anticipated to be approximately four years. Year one will be dedicated to program, protocol and evaluation design, and recruitment, selection and calibration of researcher dentists. Years two and three will be the research and data collection time period, and year four will be dedicated to evaluation.

Key facts

Study ID

NCT01176396

Run by

University of California, San Francisco

People needed

460

Starts

2012-04-01

Expected to finish

2017-05-01

Last updated by the study team

2020-04-10

Who can join

Age: 12 and older, up to 65. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• These criteria will not be based on race or gender.
• Participants will be new patients and must:
• be at least 12 years old and not older than 65 years
• be able to give informed consent in English
• be unlikely to move from the area during the study period (as determined by residential history and questioning, and be unlikely to move in the next 2.5 years for work, educational, or personal reasons.)
• be willing to participate regardless of group assignment
• be willing to comply with all study procedures and protocol
• be dentate with at least sixteen teeth
• will have all treatment needs for caries completed within three months of entry into the study

You may not qualify if…

• People who want to limit radiation exposure from dental radiographs
• Persons with:
• significant past or current medical problem history especially conditions that may affect oral health or oral flora (i.e., diabetes, HIV, heart conditions that require antibiotic prophylaxis)
• medication use that may affect the oral flora or salivary flow (e.g., antibiotic use in the past three months, drugs associated with dry mouth/xerostomia)
• root caries at enrollment (study will focus on coronal caries)
• periodontal disease that requires surgery, chemotherapeutic agents, or frequent prophys
• another household member participating in the study (to prevent sharing F, CHX rinses, etc.)
• drug or alcohol addiction, or other conditions that may decrease the likelihood of adhering to study protocol
• missed screening visit without cancellation or rescheduling
• rescheduled screening visit more than once
• subjects with extreme high caries risk
• sensitive to Chlorhexidine or the ethyl alcohol vehicle in CHX

Where it is running

• UCSF School of Dentistry - Dental Offices in Bay Area — San Francisco, California, United States

Full record on ClinicalTrials.gov

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