Lateral Window Versus Intralift™ Sinus Floor Elevation

Intraoperative and Postoperative Outcomes of Sinus Floor Elevation Using Lateral Window Technique Versus Hydrodynamic Transalveolar Approach: A Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Intraoperative Outcomes; Postoperative Outcomes
• Intervention / Treatment: Procedure: Sinus floor elevation; Device: Sinus floor elevation using an ultrasonic device

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Control - Lateral window; Standard surgical technique to access maxillary sinus for sinus floor augmentation procedure.	Procedure: Sinus floor elevation
Experimental: Test - Hydrodynamic transalveolar approach; Novel transalveolar approach (using an ultrasonic device) to access maxillary sinus for sinus floor augmentation procedure.	Device: Sinus floor elevation using an ultrasonic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sinus membrane perforation	Presence/absence of sinus membrane perforation during the surgery	During the surgery (from beginning to end)
Surgical procedure duration	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.	From beginning of surgery until the end of surgery
Edema	Presence/absence of edema postoperatively	From the end of surgery up to 1 week postoperatively
Hematoma	Presence/absence of hematoma postoperatively	From the end of surgery up to 1 week postoperatively
Postsurgical bleeding	Presence/absence of bleeding postoperatively	From the end of surgery up to 1 week postoperatively
Nasal discharge	Presence/absence of nasal discharge postoperatively	From the end of surgery up to 1 week postoperatively
NSAID consumption	Quantification of NSAID consumption per day up to 1 week postoperatively (tablets/per day)	From the end of surgery up to 1 week postoperatively
Patient related outcome measures (PROMs)	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.	From right before the surgery up to 1 week postoperatively

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University of Liege

Publications and helpful links

General Publications

• Bacevic M, Compeyron Y, Lecloux G, Rompen E, Lambert F. Intraoperative and postoperative outcomes of sinus floor elevation using the lateral window technique versus the hydrodynamic transalveolar approach: a preliminary randomized controlled trial. Clin Oral Investig. 2021 Sep;25(9):5391-5401. doi: 10.1007/s00784-021-03847-2. Epub 2021 Mar 10.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: July 14, 2020
• First Submitted That Met QC Criteria: July 31, 2020
• First Posted (Actual): August 5, 2020

Study Record Updates

• Last Update Posted (Actual): August 5, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: B707201316423

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No