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Prevention of Adult Caries Study (PACS)
This study is currently recruiting participants.
Study NCT00357877   Information provided by National Institute of Dental and Craniofacial Research (NIDCR)
First Received: July 26, 2006   Last Updated: November 24, 2008   History of Changes

July 26, 2006
November 24, 2008
July 2006
June 2009   (final data collection date for primary outcome measure)
The primary outcome variable [ Time Frame: (V1) to the 13 month follow-up visit ] [ Designated as safety issue: No ]
  • The primary outcome variable
  • is the total net caries increment
  • (root and coronal surfaces combined)
  • from randomization (V1) to the 13-month follow-up visit
  • (V6), scored as the number of changes recorded from V1 to V6,
  • including reversals.
Complete list of historical versions of study NCT00357877 on ClinicalTrials.gov Archive Site
 
 
 
Prevention of Adult Caries Study (PACS)
Prevention of Adult Caries Study

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.

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.

Phase III
Interventional
Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Root and Coronal Caries.
Drug: 10% w/v chlorhexidine varnish
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
1000
June 2010
June 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
 
United States
 
NCT00357877
Athena S. Papas, Principal Investigator, Tufts University School of Dental Medicine
DE017753-01
National Institute of Dental and Craniofacial Research (NIDCR)
 
Principal Investigator: Athena Papas, PhD DMD Tufts University of Dental Medicine
National Institute of Dental and Craniofacial Research (NIDCR)
November 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP