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Completed

NCT Number: NCT00127244

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Forsyth Institute

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Periodontal Treatment

Procedure

Primary outcomes

  1. Clinical attachment loss

  2. Quality of life

  3. Tooth loss

  4. Plaque accumulation

  5. Suppuration

  6. Bleeding on probing

Sponsors and collaborators

Lead sponsor

The Forsyth Institute

Other

Collaborators

  • Delta Dental Plan Massachusetts
  • Harvard University
  • National Institute of Dental and Craniofacial Research (NIDCR)

Registry information

Official study title

Outcomes of Traditional and Medical Models of Periodontal Therapy

Important dates

Study start
2000
Study completion
2004
First posted
Aug 5, 2005
Registry last updated
Dec 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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