Study Comparing Two Different Methods of Treating Periodontal Disease

This study has been completed.
Sponsor:
Collaborators:
Delta Dental Plan Massachusetts
Harvard University
Information provided by:
The Forsyth Institute
ClinicalTrials.gov Identifier:
NCT00127244
First received: August 4, 2005
Last updated: November 30, 2010
Last verified: November 2010
  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 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Outcomes of Traditional and Medical Models of Periodontal Therapy

Further study details as provided by The Forsyth Institute:

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
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: NCT00127244

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

No publications provided

ClinicalTrials.gov Identifier: NCT00127244     History of Changes
Other Study ID Numbers: NIDCR-13850, R01DE013850, DE-013850
Study First Received: August 4, 2005
Last Updated: November 30, 2010
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 21, 2014