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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Other: Caries prevention active intervention
* Other: control treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Caries prevention active intervention<br>Patients receive CAMBRA related products like CHX, 5000ppm F-toothpaste etc according to their risk level | Other: Caries prevention active intervention<br>* 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.<br>|
| Placebo Comparator: control treatment<br>Patients receive treatment according to standard of care | Other: control treatment<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| caries increment |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in mutans streptococci (MS), and lactobacilli (LB) in whole saliva |  | 2 years | 
| change in caries risk category over time |  | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Caries, Preventive Dentistry, Dental Prophylaxis, Dental Care