Tooth Loss Clinical Trial
Official title:
Efficacy of a Novel Simplified, Minimally-invasive Procedure for Sinus Floor Elevation in the Atrophic Posterior Maxilla: a Multicenter, Randomized Study
BACKGROUND Tooth loss impairs the OHRQoL. Dental implants have expanded treatment options of
edentulous patients and improved their OHRQoL, however, in the posterior maxillary sextants
the possibility to place implants of desired length and diameter could be limited. lSFE and
tSFE represent two surgical options to vertically enhance the available bone in the
edentulous posterior maxilla. Invasivity, relevant postoperative discomfort, high costs, and
long times needed for the finalization of the prosthetic rehabilitation, however, strongly
limit the indications of lSFE and support the need for less traumatic procedures with similar
clinical effectiveness and reduced morbidity. In 2008, the investigators proposed a
user-friendly, safe, predictable and effective minimally-invasive procedure for tSFE, namely
the Smart Lift technique.
AIMS/OBJECTIVES The general aim of the present project is to validate the Smart Lift
technique as a simplified and minimally-invasive procedure for the implant-supported
rehabilitation of patients with edentulous, atrophic maxillary posterior sextants.
METHODS In a multicenter RCT study design, the reconstructive (clinical) and patient-centered
outcomes of tSFE performed according to the Smart Lift technique will be compared with those
of conventional lSFE.
EXPECTED RESULTS The Smart Lift technique should allow for a significant reduction of
treatment time, post-surgery complications and costs and an increase in the satisfaction
perceived by the edentulous patient with implant-supported rehabilitation, while maintaining
a clinical efficacy as well as a similar or lower morbidity and discomfort when compared to
lSFE. In other words, the investigators expect that more favorable risk-benefit and
cost-utility ratio, as well as a better performance in terms of pain, comfort, physical,
social and psychological effects of oral health, and issues concerning the OHRQoL, will be
observed for the Smart Lift technique compared to lSFE.
List of Acronyms (in alphabetical order) OHRQoL: Oral Health - Related Quality of Life lSFE:
sinus floor elevation with a lateral approach RCT: randomized controlled trial tSFE: sinus
floor elevation with transcrestal approach
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