Study Comparing Two Different Methods of Treating Periodontal Disease

The Forsyth Institute

Status and phase

Completed

Phase 2

Conditions

Periodontal Diseases

Treatments

Procedure: Periodontal Treatment

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00127244

DE-013850

R01DE013850 (U.S. NIH Grant/Contract)

NIDCR-13850

Details and patient eligibility

About

The purposes of this study are to:

compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
determine the value of the two approaches to periodontal therapy.

Full 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:

this would increase access to periodontal care; and
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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria