Study Comparing Two Different Methods of Treating Periodontal Disease

Periodontal Diseases Clinical Trial

Official title:

Outcomes of Traditional and Medical Models of Periodontal Therapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00127244
• Other study ID #: NIDCR-13850
• Secondary ID: R01DE013850DE-01
• Status: Completed
• Phase: Phase 2
• First received: August 4, 2005
• Last updated: November 30, 2010
• Start date: June 2000
• Est. completion date: October 2004

Study information

• Verified date: November 2010
• Source: The Forsyth Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 400
• Est. completion date: October 2004
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases

Intervention

Procedure:
• Periodontal Treatment

Locations

Country	Name	City	State
United States	The Forsyth Institute	Boston	Massachusetts

Sponsors (4)

Lead Sponsor	Collaborator
The Forsyth Institute	Delta Dental Plan Massachusetts, Harvard University, National Institute of Dental and Craniofacial Research (NIDCR)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical attachment loss
Primary	Quality of life
Primary	Tooth loss
Primary	Plaque accumulation
Primary	Suppuration
Primary	Bleeding on probing