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Trial record 29 of 48 for:    gum disease AND oral | ( Map: United States ) | 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

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.

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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

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, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier (NCT number): NCT00127244

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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
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Principal Investigator: Richard Niederman The Forsyth Institute

Layout table for additonal information Identifier: NCT00127244     History of Changes
Other Study ID Numbers: NIDCR-13850
R01DE013850 ( U.S. NIH Grant/Contract )
First Posted: August 5, 2005    Key Record Dates
Last Update Posted: December 2, 2010
Last Verified: November 2010
Additional relevant MeSH terms:
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Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases