Lateral Window Versus Intralift™ Sinus Floor Elevation

Not Applicable

Completed

• Conditions: Intraoperative Outcomes; Postoperative Outcomes
• Interventions: Procedure: Sinus floor elevation; Device: Sinus floor elevation using an ultrasonic device

• Registration Number: NCT04499625
• Lead Sponsor: University of Liege

Brief Summary

Several approaches have been used in order to regenerate bone in the upper jaw in case of insufficient alveolar bone height for implant placement. However, new emerging techniques need to be assessed and compared to conventional methods in order to define their potential indications.

The purpose of the present randomized controlled clinical trial was to compare the clinical outcomes of two sinus floor elevation techniques: conventional lateral window technique versus a novel transalveolar approach using hydrodynamic ultrasonic device.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2020-07
• Study First Submitted: 2020-07-14
• Study First Submitted QC: 2020-07-31
• Last Update Submitted: 2020-07-31
• Study First Posted: 2020-08-05
• Last Update Posted: 2020-08-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• edentulism in the posterior maxilla (unitary or plural)
• need of a sinus floor augmentation procedure before implant placement

Exclusion Criteria

• any uncontrolled systemic disease
• ongoing chemo- or radiotherapy
• history of maxillary sinus diseases or acute sinus-related issues

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control - Lateral window	Sinus floor elevation	Standard surgical technique to access maxillary sinus for sinus floor augmentation procedure.
Test - Hydrodynamic transalveolar approach	Sinus floor elevation using an ultrasonic device	Novel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure.

Primary Outcome Measures

Name	Time	Method
Sinus membrane perforation	During the surgery (from beginning to end)	Presence/absence of sinus membrane perforation during the surgery
Surgical procedure duration	From beginning of surgery until the end of surgery	The time measurement started from the administration of local anesthesia and ended when the placement of final suture was completed. The time was measured using a stopwatch.
Edema	From the end of surgery up to 1 week postoperatively	Presence/absence of edema postoperatively
Hematoma	From the end of surgery up to 1 week postoperatively	Presence/absence of hematoma postoperatively
Postsurgical bleeding	From the end of surgery up to 1 week postoperatively	Presence/absence of bleeding postoperatively
Nasal discharge	From the end of surgery up to 1 week postoperatively	Presence/absence of nasal discharge postoperatively
NSAID consumption	From the end of surgery up to 1 week postoperatively	Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)
Patient related outcome measures (PROMs)	From right before the surgery up to 1 week postoperatively	PROMs were assessed with a questionnaire using a visual analogue scale (VAS), which was given to all participants in order to assess their perception before, during, and after the intervention. A graduated scale from 0 to 10 was used, with a lower score presenting a better outcome.

Secondary Outcome Measures

Name	Time	Method
Radiographic outcomes	From the baseline (surgery procedure) up to 1 year post-surgery	Radiographic (CBCT) qualitative assessment of the gained volume (change in volume from baseline to 1 year postoperatively).
Implant survival rates	From the baseline (surgery procedure) up to 1 year post-surgery	Implant survival rates assessment at 1 year postoperatively.