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

NCT01176396 | Completed

• 1 other identifier: UCSF A113385
• Study Type: interventional
• Target: 460
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Caries

Keywords

Dental Caries; Preventive Dentistry; Dental Prophylaxis; Dental Care

Outcome Measures

Primary Outcomes (1)

• caries increment

  2 years

Secondary Outcomes (2)

• changes in mutans streptococci (MS), and lactobacilli (LB) in whole saliva

  2 years

• change in caries risk category over time

  2 years

Study Arms (2)

Caries prevention active intervention

ACTIVE COMPARATOR

Patients receive CAMBRA related products like CHX, 5000ppm F-toothpaste etc according to their risk level

Other: Caries prevention active intervention

control treatment

PLACEBO COMPARATOR

Patients receive treatment according to standard of care

Other: control treatment

Interventions

Caries prevention active intervention OTHER

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.

Caries prevention active intervention

control treatment OTHER

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).

control treatment

Eligibility Criteria

• Age: 12 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• California Dental Association Foundation: collaborator

Study Sites (1)

UCSF School of Dentistry - Dental Offices in Bay Area

San Francisco, California, 94143, United States

Location

Related Publications (24)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  PMID: 8946102 BACKGROUND

• Beltran-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.

  PMID: 16121123 BACKGROUND

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  PMID: 12097355 BACKGROUND

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  PMID: 3476591 BACKGROUND

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  PMID: 3605476 BACKGROUND

• 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].

  BACKGROUND

• 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].

  BACKGROUND

• 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].

  BACKGROUND

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

  PMID: 17170326 BACKGROUND

• 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.

  PMID: 18080486 BACKGROUND

• 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.

  PMID: 18044376 BACKGROUND

• 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.

  PMID: 18044378 BACKGROUND

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

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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. doi: 10.1177/154405910608500212.

  PMID: 16434738 BACKGROUND

• 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.

  PMID: 19581542 BACKGROUND

• 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. doi: 10.1016/j.ijporl.2006.09.008. Epub 2006 Nov 9.

  PMID: 17097152 BACKGROUND

• 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. doi: 10.3177/jnsv.53.13.

  PMID: 17484374 BACKGROUND

• Rechmann P, Chaffee BW, Rechmann BMT, Featherstone JDB. Changes in Caries Risk in a Practice-Based Randomized Controlled Trial. Adv Dent Res. 2018 Feb;29(1):15-23. doi: 10.1177/0022034517737022.

  PMID: 29355409 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: April 1, 2012
• Primary Completion: January 1, 2017
• Study Completion: May 1, 2017
• Last Updated: April 10, 2020

Record last verified: 2020-04

Locations

US (1)