Study Comparing Two Different Methods of Treating Periodontal Disease

November 30, 2010 updated by: The Forsyth Institute

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.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • The Forsyth Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Quality of life
Clinical attachment loss
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Richard Niederman, The Forsyth Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2000

Study Completion

October 1, 2004

Study Registration Dates

First Submitted

August 4, 2005

First Submitted That Met QC Criteria

August 4, 2005

First Posted (Estimate)

August 5, 2005

Study Record Updates

Last Update Posted (Estimate)

December 2, 2010

Last Update Submitted That Met QC Criteria

November 30, 2010

Last Verified

November 1, 2010

More Information

Terms related to this study

Other Study ID Numbers

  • NIDCR-13850
  • R01DE013850 (U.S. NIH Grant/Contract)
  • DE-013850

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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