Study Comparing Two Different Methods of Treating Periodontal Disease
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
|Official Title:||Outcomes of Traditional and Medical Models of Periodontal Therapy|
- Clinical attachment loss
- Quality of life
- Tooth loss
- Plaque accumulation
- Bleeding on probing
|Study Start Date:||June 2000|
|Estimated Study Completion Date:||October 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00127244
|United States, Massachusetts|
|The Forsyth Institute|
|Boston, Massachusetts, United States, 02115|
|Principal Investigator:||Richard Niederman||The Forsyth Institute|