CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network
Condition: Dental Caries
MeSH terms: Dental Caries
Study type: Interventional

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.
    

Detailed description: 
      The clinical part of the project will prove that CAMBRA principles can successfully be
      disseminated into everyday dental practices and that by applying the principles of Caries
      Management by Risk Assessment to subjects in those practices a major reduction in caries can
      be seen in the intervention group in comparison to the control group. At the end of the two
      year clinical part performed in the Practice Based Research Network data will show that the
      positive results of the first CAMBRA study achieved in the university setting at UCSF can
      also be accomplished in a dental practice setting to the benefit of patients. If CAMBRA can
      be successfully disseminated into dental practices dental care costs can significantly be
      reduced.

      The overall study objective is to build a Practice Based Research Network (PBRN) and to
      conduct in this setting a 2-year randomized, controlled, double blind clinical trial to
      provide clinical evidence that scientifically based caries risk assessment, in conjunction
      with aggressive preventive measures and conservative restorations will result in dramatically
      reduced further caries increment. If successful this study performed in a PBRN will provide
      substantial evidence for changing the practice of caries management. The planned study is a
      double blind practice-based clinical study. The California Dental Association Foundation will
      help to select up to 30 participating dentists. Practitioners will perform a Caries
      Management by Risk Assessment (CAMBRA) evaluation and will instruct and provide treatment
      suggestions for the study subjects according to the CAMBRA protocol.

      The hypothesis to be tested is that caries management based on caries-risk status (low,
      moderate or high) will significantly reduce the need for caries restorative treatment over
      two (plus) years compared to usual dental treatment in the practice based setting. The
      primary outcome measure will be caries increment.

      At the end of the two year clinical part performed in the Practice Based Research Network
      data will show that the positive results of the first CAMBRA study achieved in the university
      setting at UCSF can also be accomplished in a dental practice setting to the benefit of
      patients. If CAMBRA can be successfully implemented into dental practices in the future
      dental care costs can significantly be reduced.
    

Intervention name(s): Caries prevention active intervention; control treatment
Intervention type(s): Other; Other
Intervention description(s): 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.; 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dental Caries; Preventive Dentistry; Dental Prophylaxis; Dental Care