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Study Comparing Two Different Methods of Treating Periodontal Disease
This study is ongoing, but not recruiting participants.
Sponsors and Collaborators: National Institute of Dental and Craniofacial Research (NIDCR)
Delta Dental Plan Massachusetts
Harvard University
Information provided by: National Institute of Dental and Craniofacial Research (NIDCR)
ClinicalTrials.gov Identifier: NCT00127244
  Purpose

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 Intervention Phase
Periodontal Diseases
Procedure: Periodontal Treatment
Phase II

U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Outcomes of Traditional and Medical Models of Periodontal Therapy

Further study details as provided by National Institute of Dental and Craniofacial Research (NIDCR):

Primary Outcome Measures:
  • Clinical attachment loss
  • Quality of life
  • Tooth loss
  • Plaque accumulation
  • Suppuration
  • Bleeding on probing

Estimated Enrollment: 400
Study Start Date: June 2000
Estimated Study Completion Date: October 2004
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127244

Locations
United States, Massachusetts
The Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Delta Dental Plan Massachusetts
Harvard University
Investigators
Principal Investigator: Richard Niederman The Forsyth Institute
  More Information

Study ID Numbers: NIDCR-13850, DE-013850
Study First Received: August 4, 2005
Last Updated: November 8, 2006
ClinicalTrials.gov Identifier: NCT00127244  
Health Authority: United States: Federal Government

Study placed in the following topic categories:
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on January 16, 2009