Prevention of Adult Caries Study (PACS)

Caries. Clinical Trial

Official title:

Prevention of Adult Caries Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00357877
• Other study ID #: DE017753-01
• Secondary ID: U01DE017753
• Status: Active, not recruiting
• Phase: Phase 3
• First received: July 26, 2006
• Last updated: December 10, 2009
• Start date: July 2006
• Est. completion date: June 2010

Study information

• Verified date: November 2009
• Source: Tufts University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reduce new decay in adult dental patients at risk for decay.

Description:

Adult dental caries, including both coronal and root caries, is an infectious disease that afflicts the majority of Americans aged 55 and older and is the most common chronic disease at midlife. In addition, adult caries wreaks a significant economic toll, and this economic toll continues to grow. Despite the high prevalence and bacterial pathogenesis of caries, no FDA-approved anti-microbial treatment for caries is available to the American dental professional. The Prevention of Adult Caries Study (PACS) is a randomized, double-blind, placebo-controlled Phase III clinical trial conducted under F.D.A. Investigational New Drug license #45,466. This study is designed to evaluate the efficacy of a topical, temporary, 10% w/v chlorhexidine dental coating in reducing caries increment in at-risk adult dental patients. This study will follow 1000 patients over a 13-month study period at four centers with vastly diffent populations. The primary endpoint for this study will be caries increment. The centers participating in this proposed reaserch are: Kaiser Permanente's Dental Plan in Portland, Oregon; Tufts University Dental Clinic in central Boston, Massachusetts; Delta Dental Massachusetts' Dental Clinic in Southborough, Massachusetts; and the dental clinic of the Tuba City Regional Health Care Corporation in Tuba City, Arizona. Kaiser Permanente's Center for Health Research in Portland, Oregon will act as the data-coordinating center, and Tufts University will act as the Administrative Center.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 983
• Est. completion date: June 2010
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age and older

• at least 20 intact natural teeth, excluding third molars

• 2 or more lesions, of which at least one must be a cavitated D2 or D3

• willing and able to provide informed consent

Exclusion Criteria

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Caries.

Intervention

Drug:
• 10% w/v chlorhexidine acetate coating FDA IND #45466
dental coating topical applied by dental professional supragingivally to the full dentition

Locations

Country	Name	City	State
United States	Dental Services of Massachusetts	Boston	Massachusetts
United States	Tufts University of Dental Medicine	Boston	Massachusetts
United States	Center for Health Research	Portland	Oregon
United States	Tuba City Regional Health Care	Tuba City	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Tufts University	National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The primary outcome variable		(V1) to the 13 month follow-up visit	No