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Study Comparing Two Different Methods of Treating Periodontal Disease

Outcomes of Traditional and Medical Models of Periodontal Therapy

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00127244
Enrollment
400
Registered
2005-08-05
Start date
2000-06-30
Completion date
2004-10-31
Last updated
2010-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Periodontal Diseases

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.

Interventions

PROCEDUREPeriodontal Treatment

Sponsors

National Institute of Dental and Craniofacial Research (NIDCR)
CollaboratorNIH
Delta Dental Plan Massachusetts
CollaboratorUNKNOWN
Harvard University
CollaboratorOTHER
The Forsyth Institute
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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.

Design outcomes

Primary

MeasureTime frame
Clinical attachment loss
Quality of life
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026