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Study Comparing Two Different Methods of Treating Periodontal Disease

This study has been completed.
National Institute of Dental and Craniofacial Research (NIDCR)
Delta Dental Plan Massachusetts
Harvard University
Information provided by:
The Forsyth Institute Identifier:
First received: August 4, 2005
Last updated: November 30, 2010
Last verified: November 2010

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
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment
Official Title: Outcomes of Traditional and Medical Models of Periodontal Therapy

Resource links provided by NLM:

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  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 identifier: NCT00127244

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
Principal Investigator: Richard Niederman The Forsyth Institute
  More Information Identifier: NCT00127244     History of Changes
Other Study ID Numbers: NIDCR-13850
R01DE013850 ( U.S. NIH Grant/Contract )
Study First Received: August 4, 2005
Last Updated: November 30, 2010

Additional relevant MeSH terms:
Periodontal Diseases
Gingival Diseases
Mouth Diseases
Stomatognathic Diseases processed this record on September 21, 2017