Clinical Investigation of Mandibular Implant Overdenture
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00066014|
Recruitment Status : Completed
First Posted : August 5, 2003
Last Update Posted : February 22, 2012
|Condition or disease||Intervention/treatment||Phase|
|Dental Implantation||Procedure: Implant Overdenture Treatment||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Investigation of Mandibular Implant Overdenture|
|Study Start Date :||November 1998|
|Actual Primary Completion Date :||January 2007|
|Actual Study Completion Date :||January 2007|
Active Comparator: treatment modalities changed for comparison
All subjects experienced all treatment modalities being studied.
Procedure: Implant Overdenture Treatment
All overdenture treatment modalities were provided to each subject using a crossover design.
- Comparison of implant overdenture clinical modalities using clinical measures to compare treatment outcomes [ Time Frame: 6 month and 12 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00066014
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond,, Virginia, United States, 23298|
|Principal Investigator:||David R Burns||Virginia Commonwealth University|