Electrocution Prevention Methods |
|
|
Clinical Trial: Study Comparing Two Different Methods of Treating Periodontal Disease
This study is no longer recruiting patients.
|
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
| Periodontal Diseases | Procedure: Periodontal Treatment | Phase II |
MedlinePlus related topics: Gum Disease
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title: Outcomes of Traditional and Medical Models of Periodontal Therapy
Expected Total Enrollment: 400
Study start: June 2000; Study completion: June 2006
Last follow-up: October 2004; Data entry closure: May 2006
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 (attachement 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.
Eligibility
Accepts Healthy Volunteers
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.
Location Information
Massachusetts
The Forsyth Institute, Boston, Massachusetts, 02115, United States
Richard Niederman, Principal Investigator, The Forsyth Institute
More Information
Last Updated: August 22, 2005
Record first received: August 4, 2005
ClinicalTrials.gov Identifier: NCT00127244
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23
Resources
- Electrocution Prevention Methods (Centers for Disease Control and Prevention)

Not Signed In -

