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Prevention of Adult Caries Study (PACS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Dental and Craniofacial Research (NIDCR)
Information provided by (Responsible Party):
Tufts University
ClinicalTrials.gov Identifier:
NCT00357877
First received: July 26, 2006
Last updated: May 15, 2017
Last verified: May 2017
  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 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.

Condition Intervention Phase
Caries, Dental Drug: 10% w/v chlorhexidine acetate coating FDA IND #45466 Other: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, 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:
  • Total Net D12FS Caries Increment (Total of Non-cavitated Lesions (D1), Cavitated Lesions (D2) and Sound Surfaces (S)) [ Time Frame: (V1) to the 13 month follow-up visit ]

    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



Secondary Outcome Measures:
  • Cumulative Net D12FS Caries Increment [ Time Frame: Visit 1, 7-month follow-up, 13-month follow-up ]
    This measure was computed similar to the total net D12FS increment, but separately scored and combined transitions from the baseline to 7-month visits and from the 7- to 13-month visits, rather than simply looking at the baseline to 13-month visits.

  • Total Crude D12FS Caries Increment [ Time Frame: V1-13-month follow-up ]
    Computed analogous to the total net D12FS caries increment, but ignoring reversals (essentially assigned them zero weight). Computed only using baseline to 13-month visit data.

  • Cumulative Crude D12FS Caries Increment [ Time Frame: Visit 1, 7-month follow-up, 13-month follow-up ]
    This is computed analogous to the cumulative net D12FS increment, but ignoring reversals by assigning them weights of zero.


Enrollment: 983
Study Start Date: July 2006
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 topically applied by dental professional supragingivally to the full dentition
Other: Placebo
Active Comparator: Active Dental Coating
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
Dental coating topically applied by dental professional supragingivally to the full dentition
Other Name: CHX

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 enrollment of 1000 at four clinical centers with vastly different populations. The centers participating in this proposed research 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. 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 treat participants in months 1(4 weekly applications) and 7(1 application) with final outcome measured at 13 months after randomization. Examiners were trained and certified before data collection started and were recalibrated annually. The primary outcome analysis in the intent -to- treat sample compares active to placebo group on the rank-normalized caries increment score, adjusting for examiner, age and age squared. Multiple imputation (data augmentation using MCMC) will be used to replace missing outcome. Planned secondary analysis examine the secondary caries increment outcomes using the same model, as well as parallel analyses in the per-protocol group. Safety of the coating will be evaluated by comparing development of resistant S. mutans or C. albicans as well as incidence of MedDRA-coded adverse events between the two arms.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Dental Services of Massachusetts
Boston, Massachusetts, United States, 02129
United States, Oregon
Center for Health Research
Portland, Oregon, United States, 97227
Sponsors and Collaborators
Tufts University
National Institute of Dental and Craniofacial Research (NIDCR)
Investigators
Principal Investigator: Athena Papas, PhD DMD Tufts University of Dental Medicine
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts University
ClinicalTrials.gov Identifier: NCT00357877     History of Changes
Other Study ID Numbers: DE017753-01
U01DE017753 ( U.S. NIH Grant/Contract )
Study First Received: July 26, 2006
Results First Received: October 18, 2016
Last Updated: May 15, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Chlorhexidine
Chlorhexidine gluconate
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants
Dermatologic Agents

ClinicalTrials.gov processed this record on July 25, 2017