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Status:

COMPLETED

Prevention of Adult Caries Study (PACS)

Lead Sponsor:

Tufts University

Collaborating Sponsors:

National Institute of Dental and Craniofacial Research (NIDCR)

Conditions:

Caries, Dental

Eligibility:

All Genders

18+ years

Phase:

PHASE3

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 f...

Detailed Description

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, with a target en...

Eligibility Criteria

Inclusion

  • 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

Exclusion

    Key Trial Info

    Start Date :

    July 1 2006

    Trial Type :

    INTERVENTIONAL

    Allocation :

    ACTUAL

    End Date :

    June 1 2010

    Estimated Enrollment :

    983 Patients enrolled

    Trial Details

    Trial ID

    NCT00357877

    Start Date

    July 1 2006

    End Date

    June 1 2010

    Last Update

    June 14 2017

    Active Locations (4)

    Enter a location and click search to find clinical trials sorted by distance.

    Page 1 of 1 (4 locations)

    1

    Tuba City Regional Health Care

    Tuba City, Arizona, United States, 86045-0600

    2

    Tufts University School of Dental Medicine

    Boston, Massachusetts, United States, 02111

    3

    Dental Services of Massachusetts

    Boston, Massachusetts, United States, 02129

    4

    Center for Health Research

    Portland, Oregon, United States, 97227