Trial record 15 of 45 for:    gum disease | NIH

Study Comparing Two Different Methods of Treating Periodontal Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00127244
Recruitment Status : Completed
First Posted : August 5, 2005
Last Update Posted : December 2, 2010
National Institute of Dental and Craniofacial Research (NIDCR)
Delta Dental Plan Massachusetts
Harvard University
Information provided by:
The Forsyth Institute

August 4, 2005
August 5, 2005
December 2, 2010
June 2000
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  • Clinical attachment loss
  • Quality of life
  • Tooth loss
  • Plaque accumulation
  • Suppuration
  • Bleeding on probing
Same as current
Complete list of historical versions of study NCT00127244 on Archive Site
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Study Comparing Two Different Methods of Treating Periodontal Disease
Outcomes of Traditional and Medical Models of Periodontal Therapy

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.

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.

Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Periodontal Diseases
Procedure: Periodontal Treatment
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2004
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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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
R01DE013850 ( U.S. NIH Grant/Contract )
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The Forsyth Institute
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • Delta Dental Plan Massachusetts
  • Harvard University
Principal Investigator: Richard Niederman The Forsyth Institute
The Forsyth Institute
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP