Clinical Investigation of Mandibular Implant Overdenture

Phase 2

Completed

• Conditions: Dental Implantation
• Interventions: Procedure: Implant Overdenture Treatment

• Registration Number: NCT00066014
• Lead Sponsor: Virginia Commonwealth University

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.

Study Timeline

• Study Start: 1998-11
• Study First Submitted: 2003-08-01
• Study First Submitted QC: 2003-08-04
• Study First Posted: 2003-08-05
• Primary Completion: 2007-01
• Study Completion: 2007-01
• Status Verified: 2010-01
• Last Update Submitted: 2012-02-21
• Last Update Posted: 2012-02-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
treatment modalities changed for comparison	Implant Overdenture Treatment	All subjects experienced all treatment modalities being studied.

Primary Outcome Measures

Name	Time	Method
Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes	6 month and 12 month

Trial Locations

Locations (1)

Virginia Commonwealth University; 🇺🇸 Richmond,, Virginia, United States