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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University of California, San Francisco
Sponsor:
Collaborator:
California Dental Association Foundation
Information provided by (Responsible Party):
Peter Rechmann, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01176396
First received: August 4, 2010
Last updated: April 28, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Dental Caries
Other: Caries prevention active intervention
Other: control treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: CAMBRA - PBRN Caries Management By Risk Assessment In A Practice-Based Research Network

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • caries increment [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • changes in mutans streptococci (MS), and lactobacilli (LB) in whole saliva [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • change in caries risk category over time [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 900
Study Start Date: April 2012
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Caries prevention active intervention Other: Caries prevention active intervention

Depending on the assessed individual caries risk level subjects will be treated related to their caries risk:

Caries Risk: "Low Risk"

The intervention and the control treatments for low caries risk are basically the same and comprise:

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

Caries Risk: "Moderate Risk" In addition to the treatment above the intervention group receives OTC fluoride rinse as well as xylitol candies or gums.

Caries Risk: "High 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.

Placebo Comparator: control treatment Other: control treatment

Depending on the assessed individual caries risk subjects will be treated related to their caries risk:

Caries Risk: "Low Risk"

The intervention and the control treatments for low caries risk are basically the same and comprise:

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

Caries Risk: "Moderate Risk" The "control" group receives regular dental care (which to keep blinding possible includes a placebo rinse and gums without active ingredients).

Caries Risk: "High Risk" The control treatment group receives regular dental care (which to keep blinding possible includes brushing with the regular 1,100 ppm F toothpaste, rinses with a placebo rinse without antibacterial ingredients and receive a placebo varnish).


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.

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01176396

Contacts
Contact: Peter Rechmann, DDS, PhD 415 514 3225 rechmannp@dentistry.ucsf.edu
Contact: John DB Featherstone, MSc, PhD 415 476 0456 jdbf@ucsf.edu

Locations
United States, California
UCSF School of Dentistry - Dental Offices in Bay Area Recruiting
San Francisco, California, United States, 94143
Contact: Peter Rechmann, DDS, PhD    415-514-3225    rechmannp@dentistry.ucsf.edu   
Principal Investigator: Peter Rechmann, DDS PhD         
Sponsors and Collaborators
University of California, San Francisco
California Dental Association Foundation
Investigators
Principal Investigator: Peter Rechmann, DDS, PhD University of California, San Francisco, School of Dentistry
Principal Investigator: John DB Featherstone, MSc, PhD University of California, San Francisco, School of Dentistry
  More Information

Publications:
NIDR. The prevalence of dental caries in United States children: The National Dental Caries Prevalence Survey: 1979-80. NIH Publication No. 82-2245. National Institutes of Health 1981.
Featherstone JDB, Gansky SA, Hoover CI, Rapozo-Hilo ML, Weintraub JA, White JM, et al. Chlorehexidine and fluoride therapy reduces caries risk. J Dent Res 2005;84 [Spec Iss A, abstract 0023].
Hoover CI, Weintraub JA, Gansky SA, White JM, Wilson RS, Featherstone JDB. Effect of a caries management regimen on cariogenic bacterial population. J Dent Res. 2004;83 [Spec Iss A, abstract 0779].
Hoover CI, Weintraub JA, Gansky SA, White JM, Wilson JA, Featherstone JDB. Effect of restorations and Bacterial Challenge Management on Cariogenic Bacteria. J Dent Res. 2005;84 [Spec Iss A, abstract 3254].
Hodge HC. The safety of fluoride tablets or drops. In: Johansen E, Tavaes DR, Olsen TO, editors. Continuing evaluation of the use of fluorides. Bolder, CO: Westview Press; 1979. p. 253-75.

Responsible Party: Peter Rechmann, DDS PhD, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01176396     History of Changes
Other Study ID Numbers: UCSF A113385
Study First Received: August 4, 2010
Last Updated: April 28, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
Dental Caries
Preventive Dentistry
Dental Prophylaxis
Dental Care

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on July 20, 2014