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

Summary

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.

Conditions

• Dental Caries

Interventions

OTHER

Caries prevention active intervention

Subjects will be treated related to their caries risk: "Low Caries Risk" The intervention and control treatments for low caries risk are the same: 4 bitewing radiographs dental prophylaxis Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) 2x daily Periodic oral exam after 12 months Bitewings after 12 months "Moderate Caries Risk" In addition to the treatment above the intervention group receives OTC fluoride rinse as well as xylitol candies or gums. "High Caries Risk" The high caries risk level subjects will receive a prescription 5,000 ppm F toothpaste, will rinse 1 day for one week per months with a Chlorhexidine rinse to reduce the bacteria level, and receive a fluoride varnish in the dental office.

OTHER

control treatment

Subjects will be treated related to their caries risk: "Low Caries Risk" The intervention and control treatments for low caries risk are the same: 4 bitewing radiographs dental prophylaxis (if prescribed) Oral Hygiene instruction OTC toothpaste with fluoride (1,100 ppm F) as currently used by patient Periodic oral exam after 12 months Bitewings after 12 months "Moderate Caries Risk" "Control" group receives regular dental care (placebo rinse and gums without active ingredients allow blinding). "High Caries Risk" The control treatment group receives regular dental care (regular 1,100 ppm F toothpaste, a placebo rinse without antibacterial ingredients and placebo varnish to allow blinding).

Sponsors & Collaborators

• California Dental Association Foundation

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Peter Rechmann, DDS, PhD · University of California, San Francisco, School of Dentistry

• John DB Featherstone, MSc, PhD · University of California, San Francisco, School of Dentistry

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2012-04-30

Primary Completion

2017-01-31

Completion

2017-05-31

Countries

• United States

Study Locations