Randomized, prospective, clinical evaluation of prosthodontic modalities for mandibular implant overdenture treatment.

摘要

STATEMENT OF PROBLEM: Mandibular implant overdentures provide improved treatment outcome than conventional denture therapy, but there is controversy as to which overdenture treatment is the best choice. PURPOSE: This study evaluated 3 different mandibular implant overdenture treatments with respect to prosthesis retention and stability, tissue response, patient satisfaction and preference, and complications to determine treatment outcomes. MATERIAL AND METHODS: In a prospective, randomized clinical trial, using a crossover design, 30 subjects (mean age, 58.9; 63% male) received 4 implants in the anterior mandible. For each subject, 3 different overdenture attachment types were fabricated and/or fitted to the implants. These included a 4-implant bar attachment fitted to all 4 implants, a 2-implant bar attachment, and 2 independent ball attachments. Subjects were randomly assigned to 1 of 6 possible treatment sequences and received all 3 attachment types each for approximately 1 year. Data were collected at baseline, and at 6 and 12 months for treatment types. Denture retention and stability and parameters of soft tissue response were recorded. Complications were documented and questionnaires were used to identify subject masticatory ability, denture complaints, and preferences. Data were analyzed to determine statistical equivalence among the 3 different treatments using the Schuirmann's two one-sided test (TOST) procedure, and the Wilcoxon-Mann-Whitney TOST procedure (alpha=.05). RESULTS: Force gauge prosthesis retention measurements showed that the 3 treatment types were not statistically equivalent, with the 4-implant bar demonstrating the greatest retention. Criterion-based retention scores were statistically equivalent for all treatments. Both the force gauge and criterion-based prosthesis stability measurements were statistically equivalent among all 3 treatment types. Analysis of all other multiple criterion-based scoring systems indicated the majority of these variables demonstrated equivalence. Where equivalence was not identified, the most favorable responses were typically found with the O-ring treatment, and the least favorable with the 4-implant bar treatment. From the small percentage of treatment visits demonstrating minor complications, no single treatment presented with greater complications than the others. For the treatment preference among subjects, 52% selected the independent ball attachment, 32% the 4-implant bar, and 16% the 2-implant bar (P=.10). CONCLUSIONS: The 2-implant independent treatment used in this study provided equivalent or more favorable treatment outcomes for most measured parameters relative to the more complex and costly 2- and 4-implant bar attachments. The 4-implant bar treatment provided greater prosthesis retention than the other treatment types in this study, but after experience with all systems, subjects were more satisfied with and preferred the independent implant treatment.