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

Dental Caries Clinical Trial

— CAMBRA-PBRN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176396
• Other study ID #: UCSF A113385
• Status: Completed
• Phase: N/A
• Start date: April 2012
• Est. completion date: May 2017

Study information

• Verified date: April 2020
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 460
• Est. completion date: May 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	UCSF School of Dentistry - Dental Offices in Bay Area	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	California Dental Association Foundation

Country where clinical trial is conducted

United States, 

References & Publications (23)

American Dental Association. Fluoridation Facts. Chicago. IL; 2005.

Beltrán-Aguilar ED, Barker LK, Canto MT, Dye BA, Gooch BF, Griffin SO, Hyman J, Jaramillo F, Kingman A, Nowjack-Raymer R, Selwitz RH, Wu T; Centers for Disease Control and Prevention (CDC). Surveillance for dental caries, dental sealants, tooth retention, edentulism, and enamel fluorosis--United States, 1988-1994 and 1999-2002. MMWR Surveill Summ. 2005 Aug 26;54(3):1-43. — View Citation

Bowen WH. Do we need to be concerned about dental caries in the coming millennium? Crit Rev Oral Biol Med. 2002;13(2):126-31. Review. — View Citation

Brunelle JA. Oral Health of United States Children: The National Survey of Dental caries in US School Children:1986-87. National Institute of Dental Research 1989.

Doméjean-Orliaguet S, Gansky SA, Featherstone JD. Caries risk assessment in an educational environment. J Dent Educ. 2006 Dec;70(12):1346-54. — View Citation

Featherstone JD, Domejean-Orliaguet S, Jenson L, Wolff M, Young DA. Caries risk assessment in practice for age 6 through adult. J Calif Dent Assoc. 2007 Oct;35(10):703-7, 710-3. — View Citation

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].

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.

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].

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].

Institute of Medicine, Food and Nutrition Board. Dietary reference intakes for calcium, phosphorus, magnesium, vitamin D and fluoride. Report of the Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Washington, DC: National Academy Press; 1997.

Ismail AI, Burt BA, Brunelle JA. Prevalence of total tooth loss, dental caries, and periodontal disease in Mexican-American adults: results from the southwestern HHANES. J Dent Res. 1987 Jun;66(6):1183-8. — View Citation

Ismail AL, Burt BA, Brunelle JA. Prevalence of dental caries and periodontal disease in Mexican American children aged 5 to 17 years: results from southwestern HHANES, 1982-83. National Health and Nutrition Examination Survey. Am J Public Health. 1987 Aug;77(8):967-70. — View Citation

Kaste LM, Selwitz RH, Oldakowski RJ, Brunelle JA, Winn DM, Brown LJ. Coronal caries in the primary and permanent dentition of children and adolescents 1-17 years of age: United States, 1988-1991. J Dent Res. 1996 Feb;75 Spec No:631-41. — View Citation

Milgrom P, Ly KA, Roberts MC, Rothen M, Mueller G, Yamaguchi DK. Mutans streptococci dose response to xylitol chewing gum. J Dent Res. 2006 Feb;85(2):177-81. — View Citation

Milgrom P, Ly KA, Tut OK, Mancl L, Roberts MC, Briand K, Gancio MJ. Xylitol pediatric topical oral syrup to prevent dental caries: a double-blind randomized clinical trial of efficacy. Arch Pediatr Adolesc Med. 2009 Jul;163(7):601-7. doi: 10.1001/archpediatrics.2009.77. — View Citation

NCHS. National Center for Heath Statistics, Government Printing Office, Washington D.C. 1974.

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.

Oku T, Nakamura S. Threshold for transitory diarrhea induced by ingestion of xylitol and lactitol in young male and female adults. J Nutr Sci Vitaminol (Tokyo). 2007 Feb;53(1):13-20. — View Citation

Speechley M, Johnston DW. Some evidence from Ontario, Canada, of a reversal in the dental caries decline. Caries Res. 1996;30(6):423-7. — View Citation

Vernacchio L, Vezina RM, Mitchell AA. Tolerability of oral xylitol solution in young children: implications for otitis media prophylaxis. Int J Pediatr Otorhinolaryngol. 2007 Jan;71(1):89-94. Epub 2006 Nov 9. — View Citation

Young DA, Featherstone JD, Roth JR, Anderson M, Autio-Gold J, Christensen GJ, Fontana M, Kutsch VK, Peters MC, Simonsen RJ, Wolff MS. Caries management by risk assessment: implementation guidelines. J Calif Dent Assoc. 2007 Nov;35(11):799-805. — View Citation

Young DA, Featherstone JD, Roth JR. Curing the silent epidemic: caries management in the 21st century and beyond. J Calif Dent Assoc. 2007 Oct;35(10):681-5. — View Citation

* Note: There are 23 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	caries increment		2 years
Secondary	changes in mutans streptococci (MS), and lactobacilli (LB) in whole saliva		2 years
Secondary	change in caries risk category over time		2 years