Dental Implantation Clinical Trial
Official title:
Clinical Investigation of Mandibular Implant Overdenture
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.
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.
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Allocation: Randomized, Endpoint Classification: Bio-equivalence Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
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