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Clinical Trials/NCT00066014
NCT00066014
Completed
Phase 2

Clinical Investigation of Mandibular Implant Overdenture

Virginia Commonwealth University1 site in 1 country30 target enrollmentNovember 1998

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Dental Implantation
Sponsor
Virginia Commonwealth University
Enrollment
30
Locations
1
Primary Endpoint
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes
Status
Completed
Last Updated
14 years ago

Overview

Brief Summary

The purpose of this study is to compare the effectiveness of three variable dental implant attachment methodologies in conjunction with lower dental-implant retained/supported complete overdenture treatment. These three methods are all presently used by dental practitioners, but vary significantly in terms of added treatment cost and complexity. The study tests the hypothesis that the least complex and costly method provides an equivalent treatment outcome to other more complex and costly methods.

Detailed Description

This project utilizes 30 subjects in a prospective, randomly assigned clinical study that uses a four-period, six sequence, three treatment crossover design to test the hypothesis that defined outcomes of variable implant overdenture treatments are equivalent. The project tests three overdenture treatment modalities, (1) four-implant, bar/clip-attached treatment, (2) two-implant, bar/clip-attached treatment, and (3) two-implant independently attached (O-ring) treatment. Each subject has four dental implants placed into the anterior mandible and new dentures are fabricated. After successful implant integration, subjects are randomly assigned to one of six sequences of treatment. Each treatment is followed for data collection for at least twelve months before the mandibular denture is modified to incorporate the next treatment in the sequence. Equivalence is measured in terms of prosthesis retention, stability, supporting and peri-implant tissue response, patient satisfaction/preference and treatment complications/failures. Information from this study will assist dental practitioners during treatment planning in selecting appropriate and cost effective treatment choices. There is an inverse relationship between edentulism in the U.S. population and socioeconomic status. If less costly and simplified treatment methods are shown to provide an equivalent treatment outcome to more costly/complex methods, these simplified treatments can be used to treat a larger percentage of the edentulous population.

Registry
clinicaltrials.gov
Start Date
November 1998
End Date
January 2007
Last Updated
14 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes

Time Frame: 6 month and 12 month

Study Sites (1)

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