CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network
| Status: | Recruiting |
|---|---|
| Conditions: | Other Indications, Dental |
| Therapuetic Areas: | Dental / Maxillofacial Surgery, Other |
| Healthy: | No |
| Age Range: | 12 - 65 |
| Updated: | 11/24/2016 |
| Start Date: | April 2012 |
| End Date: | April 2017 |
| Contact: | Peter Rechmann, DDS, PhD |
| Email: | rechmannp@dentistry.ucsf.edu |
| Phone: | 415 514 3225 |
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.
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.
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.
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.
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
We found this trial at
1
site
San Francisco, California 94143
Principal Investigator: Peter Rechmann, DDS PhD
Phone: 415-514-3225
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