Prevention of Adult Caries Study (PACS)

NCT00357877 | Completed Phase 3 Results DMC

• 2 other identifiers: DE017753-01U01DE017753
• Study Type: interventional
• Target: 983
• Locations: 1 country
• Sites: 4

Brief Summary

Adult tooth decay is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife with an ever growing economic toll. Despite the fact that specific bacteria cause tooth decay, no FDA-approved anti-microbial treatment for decay is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a study designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing new decay in adult dental patients at risk for decay.

Conditions

Caries, Dental

Outcome Measures

Primary Outcomes (1)

• Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S))

  Study duration was too short to have progression from D2 (cavitated lesions) to D3 (cavitated lesions that involved dentin). D2 and D3 were treated equivalently for analysis. This measure is computed as the sum of weighted counts of transitions in tooth surface status (root and coronal surfaces combined) from randomization to the 13-month follow-up visit. Disease progression had a positive weight (e.g., S-to-D1 (sound to non-cavitated lesion) or D1-to-D2 (non-cavitated to cavitated lesion) = 1, S-to-D2 (sound to cavitated lesion)= 2). Reversal had a negative weight (e.g., D1-to-S = -1). No change, transitions to or from missing or unscorable, and impossible transitions had 0 weight. Incident fillings and crowns were treated the same as incident D2 lesions for purposes of scoring. More details of the transition weights may be found at Vollmer WM et al. (2010). Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a

  (V1) to the 13 month follow-up visit

Secondary Outcomes (3)

• Cumulative Net D12FS Caries Increment

  Visit 1, 7-month follow-up, 13-month follow-up

• Total Crude D12FS Caries Increment

  V1-13-month follow-up

• Cumulative Crude D12FS Caries Increment

  Visit 1, 7-month follow-up, 13-month follow-up

Study Arms (2)

Placebo Dental Coating

PLACEBO COMPARATOR

Dental coating with all ingredients except Chlorhexidine topically applied by dental professional supragingivally to the full dentition

Other: Placebo

Active Dental Coating

ACTIVE COMPARATOR

10% w/v chlorhexidine acetate coating FDA IND #45466. Dental coating with all ingredients including Chlorhexidine topically applied by dental professional supragingivally to the full dentition

Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466

Interventions

10% w/v chlorhexidine acetate coating FDA IND #45466 DRUG

Dental coating topically applied by dental professional supragingivally to the full dentition

Also known as: CHX

Active Dental Coating

Placebo OTHER

Placebo Dental Coating

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age and older
• at least 20 intact natural teeth, excluding third molars
• or more lesions, of which at least one must be a cavitated D2 or D3
• willing and able to provide informed consent

You may not qualify if:

• pregnant or planning to become pregnant or planning to become pregnant during the study (breastfeeding is permitted)
• use of fixed orthodontic appliances
• allergic to any of the ingredients of the study medication
• long-term antibiotic therapy
• a history of, or currently active, radiation therapy for cancers of the head or neck
• Sjögren's syndrome
• advanced periodontitis
• consumption of the equivalent of more than five servings of acidic or sugared drinks per day
• having 10 or more lesions requiring restorative care at the time of the screening visit
• remineralization therapy within one month of randomization
• investigator discretion

Sponsors & Collaborators

• Tufts University: lead
• National Institute of Dental and Craniofacial Research (NIDCR): collaborator

Study Sites (4)

Tuba City Regional Health Care

Tuba City, Arizona, 86045-0600, United States

Location

Tufts University School of Dental Medicine

Boston, Massachusetts, 02111, United States

Location

Dental Services of Massachusetts

Boston, Massachusetts, 02129, United States

Location

Center for Health Research

Portland, Oregon, 97227, United States

Location

Related Publications (4)

• Papas AS, Vollmer WM, Gullion CM, Bader J, Laws R, Fellows J, Hollis JF, Maupome G, Singh ML, Snyder J, Blanchard P; PACS Collaborative Group. Efficacy of chlorhexidine varnish for the prevention of adult caries: a randomized trial. J Dent Res. 2012 Feb;91(2):150-5. doi: 10.1177/0022034511424154. Epub 2011 Dec 7.

  PMID: 22156917 RESULT

• Singh M, Papas A, Vollmer W, Bader J, Laws R, Maupome G, Snyder J, Blanchard P. Predictors of coronal caries progression in adults: results from the Prevention of Adult Caries Study. Community Dent Oral Epidemiol. 2013 Dec;41(6):558-64. doi: 10.1111/cdoe.12059. Epub 2013 Jul 9.

  PMID: 23834229 DERIVED

• Banting DW, Amaechi BT, Bader JD, Blanchard P, Gilbert GH, Gullion CM, Holland JC, Makhija SK, Papas A, Ritter AV, Singh ML, Vollmer WM. Examiner training and reliability in two randomized clinical trials of adult dental caries. J Public Health Dent. 2011 Fall;71(4):335-44. doi: 10.1111/j.1752-7325.2011.00278.x. Epub 2011 Aug 17.

  PMID: 22320292 DERIVED

• Vollmer WM, Papas AS, Bader JD, Maupome G, Gullion CM, Hollis JF, Snyder JJ, Fellows JL, Laws RL, White BA; PACS Collaborative Research Group. Design of the Prevention of Adult Caries Study (PACS): a randomized clinical trial assessing the effect of a chlorhexidine dental coating for the prevention of adult caries. BMC Oral Health. 2010 Oct 5;10:23. doi: 10.1186/1472-6831-10-23.

  PMID: 20923557 DERIVED

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Dr. William Vollmer
• Organization: Kaiser Permanente Data Coordinating Center

william.vollmer@kpchr.org

503-335-6755

Study Officials

• Athena Papas, PhD DMD

  Tufts University of Dental Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 26, 2006
• First Posted: July 28, 2006
• Study Start: July 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: June 1, 2010
• Last Updated: June 14, 2017
• Results First Posted: June 14, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)