Study Comparing Two Different Methods of Treating Periodontal Disease

Phase 2

Completed

• Conditions: Periodontal Diseases

• Registration Number: NCT00127244
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2000-06
• Study Completion: 2004-10
• Study First Submitted: 2005-08-04
• Study First Submitted QC: 2005-08-04
• Study First Posted: 2005-08-05
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-30
• Last Update Posted: 2010-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing
Clinical attachment loss
Quality of life

Trial Locations

Locations (1)

The Forsyth Institute; 🇺🇸 Boston, Massachusetts, United States