Study Comparing Two Different Methods of Treating Periodontal Disease
Primary Purpose
Periodontal Diseases
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Periodontal Treatment
Sponsored by
About this trial
This is an interventional treatment trial for Periodontal Diseases
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.
Sites / Locations
- The Forsyth Institute
Outcomes
Primary Outcome Measures
Clinical attachment loss
Quality of life
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing
Secondary Outcome Measures
Full Information
NCT ID
NCT00127244
First Posted
August 4, 2005
Last Updated
November 30, 2010
Sponsor
The Forsyth Institute
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), Delta Dental Plan Massachusetts, Harvard University
1. Study Identification
Unique Protocol Identification Number
NCT00127244
Brief Title
Study Comparing Two Different Methods of Treating Periodontal Disease
Official Title
Outcomes of Traditional and Medical Models of Periodontal Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2010
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The Forsyth Institute
Collaborators
National Institute of Dental and Craniofacial Research (NIDCR), Delta Dental Plan Massachusetts, Harvard University
4. Oversight
5. Study Description
Brief Summary
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontal Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Non-Randomized
Enrollment
400 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Periodontal Treatment
Primary Outcome Measure Information:
Title
Clinical attachment loss
Title
Quality of life
Title
Tooth loss
Title
Plaque accumulation
Title
Suppuration
Title
Bleeding on probing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Niederman
Organizational Affiliation
The Forsyth Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Forsyth Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study Comparing Two Different Methods of Treating Periodontal Disease
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