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EFFICACY OF IMPLANT SUPPORTED MAXILLOFACIAL PROSTHESES

$336,565R01FY2000DENIH

University Of California Los Angeles, Los Angeles CA

Investigators

Linked publications & trials

Abstract

DESCRIPTION (Adapted from the Applicant's Abstract): It is suggested that, objective outcome assessments are needed to determine the effectiveness of costly, time-consuming surgical reconstructive procedures and implant-supported dental prostheses prior to their acceptance as treatment modalities of choice for oral cancer patients. The investigators outline a longitudinal study to test three hypotheses: (1) the conventional dental prosthesis restores specified oral functions and perceptions to the pre-cancer levels; (2) the implant-supported dental prosthesis restores oral functions and oral perceptions to the pre-cancer surgery levels; and (3) the conventional denture and implant-supported prostheses are equally efficient in restoring specified oral functions and perceptions. A total of 62 patients with early oral cancer will be recruited; in addition, 22 patients requiring a partial maxillectomy and 40 requiring a partial lateral mandibulectomy will be enrolled. The mandibular defects will be reconstructed with fibula free flap surgery. Following a healing period, implants will be placed and permitted to heal unloaded for six months. Conventional dental prostheses will be fabricated and used by patients for at least 16 weeks during Phase I healing before the implants are exposed and loaded. A few weeks after Phase II surgery, the patients will receive implant-supported dental prostheses. A complete series of oral functional tests and questionnaires will be administered at four time intervals: (1) prior to ablative surgery; (2) one week before insertion of conventional denture prostheses; (3) 16 weeks after conventional dental prostheses insertion; and (4) 16 weeks after implant-supported dental prostheses insertion. All patients will be followed at 6 month intervals, for 12-36 months, to establish implant success rates, using life table analysis.

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