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Study Comparing Two Different Methods of Treating Periodontal Disease

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ClinicalTrials.gov Identifier: NCT00127244
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : December 2, 2010
Sponsor:
Collaborators:
National Institute of Dental and Craniofacial Research (NIDCR)
Delta Dental Plan Massachusetts
Harvard University
Information provided by:
The Forsyth Institute

Brief Summary:

The purposes of this study are to:

  1. compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
  2. determine the value of the two approaches to periodontal therapy.

Condition or disease Intervention/treatment Phase
Periodontal Diseases Procedure: Periodontal Treatment Phase 2

Detailed Description:

This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis.

There are two significant reasons for testing a medical model of care. If the hypothesis is correct:

  1. this would increase access to periodontal care; and
  2. it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems.

These points argue for a direct comparison of the medical and traditional models of care.


Study Type : Interventional  (Clinical Trial)
Enrollment : 400 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Outcomes of Traditional and Medical Models of Periodontal Therapy
Study Start Date : June 2000
Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources




Primary Outcome Measures :
  1. Clinical attachment loss
  2. Quality of life
  3. Tooth loss
  4. Plaque accumulation
  5. Suppuration
  6. Bleeding on probing


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • >/= 4 or more periodontally involved teeth as defined by pocket depth of >/= 6mm.
  • >/= 14 teeth.
  • > 18 years of age.
  • Reside in the greater Boston area.

Exclusion Criteria:

  • Those patients requiring prophylactic antibiotic for dental treatment.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00127244


Locations
United States, Massachusetts
The Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
The Forsyth Institute
National Institute of Dental and Craniofacial Research (NIDCR)
Delta Dental Plan Massachusetts
Harvard University
Investigators
Principal Investigator: Richard Niederman The Forsyth Institute

ClinicalTrials.gov Identifier: NCT00127244     History of Changes
Other Study ID Numbers: NIDCR-13850
R01DE013850 ( U.S. NIH Grant/Contract )
DE-013850
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases