NCT02415946

Sinus Lift: Saving Time and Reducing Morbidity

Efficacy of a Novel Simplified, Minimally-invasive Procedure for Sinus Floor Elevation in the Atrophic Posterior Maxilla: a Multicenter, Randomized Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 57 (actual)
• Sponsor: University Hospital of Ferrara · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Tooth Loss
• Bone Atrophy

Interventions

Type	Name	Description
PROCEDURE	Sinus floor augmentation (lateral)
PROCEDURE	Sinus floor augmentation (transcrestal)

Timeline

• Start date: 2015-02-01
• Primary completion: 2018-01-01
• Completion: 2018-01-01
• First posted: 2015-04-14
• Last updated: 2018-02-26

Locations

2 sites across 1 country: Italy