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Clinical Trials/NCT00127244
NCT00127244CompletedPhase 2

Outcomes of Traditional and Medical Models of Periodontal Therapy

The Forsyth Institute1 site in 1 country400 target enrollmentStarted: June 1, 2000Last updated:
Conditions

Trial Snapshot

Phase
Phase 2
Status
Completed
Enrollment
400
Locations
1
Primary Endpoint
Tooth loss

Study Overview

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.

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
Allocation
Non Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Outcomes

Primary Outcomes

Tooth loss

Plaque accumulation

Suppuration

Bleeding on probing

Clinical attachment loss

Quality of life

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other

Study Sites (1)

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