Study Comparing Two Different Methods of Treating Periodontal Disease

• ClinicalTrials.gov Identifier: NCT00127244
• Recruitment Status: Completed
• First Posted: August 5, 2005
• Last Update Posted: December 2, 2010
• Sponsor: The Forsyth Institute
• Collaborators: National Institute of Dental and Craniofacial Research (NIDCR); Delta Dental Plan Massachusetts; Harvard University
• Information provided by: The Forsyth Institute

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Periodontal Diseases	Procedure: Periodontal Treatment	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 400 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: Single
• Primary Purpose: Treatment
• Official Title: Outcomes of Traditional and Medical Models of Periodontal Therapy
• Study Start Date: June 2000
• Study Completion Date: October 2004

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Clinical attachment loss
2. Quality of life
3. Tooth loss
4. Plaque accumulation
5. Suppuration
6. Bleeding on probing

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

United States, Massachusetts

The Forsyth Institute

Boston, Massachusetts, United States, 02115

Sponsors and Collaborators

The Forsyth Institute

National Institute of Dental and Craniofacial Research (NIDCR)

Delta Dental Plan Massachusetts

Harvard University

Investigators

• Principal Investigator: Richard Niederman; The Forsyth Institute

More Information

• ClinicalTrials.gov Identifier: NCT00127244 History of Changes
• Other Study ID Numbers: NIDCR-13850; R01DE013850 ( U.S. NIH Grant/Contract ); DE-013850
• First Posted: August 5, 2005
• Last Update Posted: December 2, 2010
• Last Verified: November 2010

Additional relevant MeSH terms:

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases