PROJECT SUMMARY Maxillary overdentures supported by four implants have clearly shown to be effective and provide improved function as compared to conventional dentures, particularly when alveolar ridges are resorbed and when palate form is shallow. This preliminary, descriptive study aims to prospectively study the efficacy of only 2 implants to support maxillary complete dentures. The specific aims of this study are: 1) To generate an estimate of three-year implant and prosthesis success for two implant-retained maxillary complete denture prostheses; and 2) To better understand patient reported outcomes across time. Upon IRB approval and patient recruitment into the trial using pre-determined inclusion and exclusion criteria, 20 maxillary edentulous patients will be provided with two implants to support their existing denture. Each patient will receive two dental implants bilaterallly in the maxillary anterior region at the lateral incisor/canine regions. After successful osseointegration, two "Locator" abutments will be inserted over the implants and the patient's existing denture will be attached to the abutments through a laboratory reline of the denture and thus converted to a two-implant retained maxillary overdenture. Thereafter follow-up exams will be performed and clinical outcomes and patient-reported outcomes will be studied at baseline (conventional complete dentures); 1 week post-insertion of relined maxillary overdenture; 6-months; 1 year post-insertion; 2 years post-insertion; and 3 years post-insertion (all two-implant supported maxillary overdenture). The clinical outcomes will be recorded in a descriptive manner for variables including implant survival, surgical complications, radiographic bone levels, plaque index/bleeding index around the implants, prosthetic complication, wear or loosening of the abutments, replacement of the nylon inserts and other descriptive variables. The patient-reported outcomes will be recorded at follow-up appointments using a visual analog scale (VAS) and a modified oral health impact profile (OHIP-14). Additional follow-ups as required by each patient for any adverse outcomes related to treatment will also be documented. Those variables that allow comparison to conventional denture will be compared using statistical measures. SPECIFIC AIMS This descriptive, patient based study is designed to determine implant survival for dental implants and the success of implant retained complete removable prostheses when only two implants are utilized. It is well known that there is a projected increase in the number of edentulous patients in the United States. It is also known that maxillary edentulism is more common than mandibular edentulism. While the general standard of care for complete tooth replacement in the maxillary arch is the "conventional" complete denture, it is well established that maxillary implant overdenture supported by four implants generally outperforms the conventional denture. The objective of this study is to determine whether placement of a minimal number (2) of implants supporting a maxillary overdenture can result in good implant / prosthesis survival and satisfactory patient satisfaction and quality of life. Positive results from this pilot study can be used to generate hypotheses supporting a larger clinical study that may have an impact in re-defining the minimal intervention necessary for rehabilitation of the edentulous maxilla. We plan to accomplish our objectives by the pursuing the following two specific aims: To generate an estimate of three-year implant and prosthesis success for two-implant retained maxillary complete denture prostheses. The clinical outcomes will be recorded in a descriptive manner for variables including implant survival, surgical complications, radiographic bone levels, plaque index/bleeding index around the implant.
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