Lateral Window Versus Intralift™ Sinus Floor Elevation

Study Overview
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Brief Summary
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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.

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

Conditions
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Intraoperative Outcomes, Postoperative Outcomes

Intervention / Treatment
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* Procedure: Sinus floor elevation
* Device: Sinus floor elevation using an ultrasonic device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |