Study Comparing Two Different Methods of Treating Periodontal Disease

NCT ID: NCT00127244

Last Updated: 2010-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-06-30
• Study Completion Date: 2004-10-31

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.

Conditions

Periodontal Diseases

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Interventions

Periodontal Treatment

Intervention Type: PROCEDURE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role: collaborator

Delta Dental Plan Massachusetts

UNKNOWN

Sponsor Role: collaborator

Harvard University

OTHER

Sponsor Role: collaborator

The Forsyth Institute

OTHER

Sponsor Role: lead

Principal Investigators

Richard Niederman

Role: PRINCIPAL_INVESTIGATOR

The Forsyth Institute

Locations

The Forsyth Institute

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

R01DE013850

Identifier Type: NIH

Identifier Source: secondary_id

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DE-013850

Identifier Type: -

Identifier Source: secondary_id

NIDCR-13850

Identifier Type: -

Identifier Source: org_study_id