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Prevention of Adult Caries Study (PACS)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2009 by Tufts University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by:
Tufts University
ClinicalTrials.gov Identifier:
NCT00357877
First received: July 26, 2006
Last updated: December 10, 2009
Last verified: November 2009
  Purpose

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.


Condition Intervention Phase
Caries.
Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Prevention of Adult Caries Study

Resource links provided by NLM:


Further study details as provided by Tufts University:

Primary Outcome Measures:
  • The primary outcome variable [ Time Frame: (V1) to the 13 month follow-up visit ] [ Designated as safety issue: No ]

Enrollment: 983
Study Start Date: July 2006
Estimated Study Completion Date: June 2010
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo Dental Coating
Dental coating with all ingredients except chlorhexidine applied by dental professional supragingivally to the full dentition
Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466
dental coating topical applied by dental professional supragingivally to the full dentition

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00357877

Locations
United States, Arizona
Tuba City Regional Health Care
Tuba City, Arizona, United States, 86045-0600
United States, Massachusetts
Dental Services of Massachusetts
Boston, Massachusetts, United States, 02129
Tufts University of Dental Medicine
Boston, Massachusetts, United States, 02111
United States, Oregon
Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Tufts University
Investigators
Principal Investigator: Athena Papas, PhD DMD Tufts University of Dental Medicine
  More Information

No publications provided by Tufts University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Athena S. Papas, Principal Investigator, Tufts University School of Dental Medicine
ClinicalTrials.gov Identifier: NCT00357877     History of Changes
Other Study ID Numbers: DE017753-01, U01DE017753
Study First Received: July 26, 2006
Last Updated: December 10, 2009
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents
Anti-Infective Agents, Local
Dermatologic Agents
Disinfectants
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014