Study Comparing Two Different Methods of Treating Periodontal Disease
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.
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.
Allocation: Non-Randomized, Control: Active Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
The Forsyth Institute
National Institute of Dental and Craniofacial Research (NIDCR)
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00127244
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Periodontal Attachment Loss
Loss or destruction of periodontal tissue caused by periodontitis or other destructive periodontal diseases or by injury during instrumentation. Attachment refers to the periodontal ligament which attaches to the alveolar bone. It has been hypothesized that treatment of the underlying periodontal disease and the seeding of periodontal ligament cells enable the creating of new attachment.
Any restorative and replacement device that is used as a therapeutic aid in the treatment of periodontal disease. It is an adjunct to other forms of periodontal therapy and does not cure periodontal disease by itself. (Boucher's Clinical Dental Terminology, 3d ed)
A numerical rating scale for classifying the periodontal status of a person or population with a single figure which takes into consideration prevalence as well as severity of the condition. It is based upon probe measurement of periodontal pockets and on gingival tissue status.
Pathological processes involving the PERIODONTIUM including the gum (GINGIVA), the alveolar bone (ALVEOLAR PROCESS), the DENTAL CEMENTUM, and the PERIODONTAL LIGAMENT.
A species of bacteria in the family SPIROCHAETACEAE, frequently isolated from periodontal pockets (PERIODONTAL POCKET).
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