Advanced Intelligence Driven Drill for Maxillary Sinus Augmentation in Patients with Severe Bone Loss

Summary

Study Summary

The goal of this clinical trial is to evaluate whether a newly designed Advanced Intelligent drill can improve the safety and effectiveness of Maxillary Sinus Floor Augmentation (MSFA) procedures in adults with insufficient bone height in the posterior maxilla for dental implants.

The main questions it aims to answer are:

* Can the AI drill reduce the risk of Schneiderian membrane perforation compared to traditional drilling methods?
* Does the AI drill improve the efficiency of window preparation during the procedure?

The researcher compares the outcomes of participants treated with the AI drill to those treated with a traditional rotary drill to see if the AI drill leads to fewer complications (less membrane perforations, bleeding and postoperative complications) and better surgical outcomes.

Participants will:

* Undergo MSFA using either the AI-powered drill or the traditional rotary drill.
* Attend follow-up appointments to monitor healing and outcomes, including imaging and clinical evaluations.

This study hopes to advance surgical techniques for safer and more effective preparation for dental implants.

Conditions

• Maxillary Sinus Floor Augmentation

Interventions

DEVICE

Advanced intelligence drill

The AI drill is an innovative surgical tool designed specifically for Maxillary Sinus Floor Augmentation (MSFA) procedures. It incorporates advanced technology to enhance safety, precision, and efficiency during lateral window preparation. It has an Automated Pressure-Sensing Mechanism which makes the drill automatically stops rotating when it detects contact with the Schneiderian membrane, minimizing the risk of perforation. The OLA kit consists of Hydraulic Lift which is compatibility with the drill connected to a saline-filled syringe to gently elevate the Schneiderian membrane from the sinus floor. It involves a Multi-Step Drilling Process using different drill tips designed each for a specific task including the pilot drill for initial window creation and the non-cutting ball-end drill for lateral wall thinning and smoothing. It works at a controlled high-Speed Performance of 6000 RPM with irrigation system included.

DEVICE

Traditional rotary instrument

Traditional Rotary Drill The traditional rotary drill is a commonly used surgical tool in Maxillary Sinus Floor Augmentation (MSFA) procedures, employing conventional drilling techniques for lateral window preparation. It is a widely recognized method due to its accessibility and effectiveness in skilled hands. It Uses a rose-head bur attached to a surgical straight handpiece that operates at speeds of 800-1200 RPM with irrigation to prevent overheating and ensure efficient bone cutting. It is a manual operator control that requires the surgeon's skill and experience to control the depth and force of drilling. And relies on visual and tactile feedback to identify when the Schneiderian membrane is close to exposure. It is versatile and can be adapted to varying bone densities and anatomical complexities. It is effective for creating the window for sinus access. It comes with an irrigation system to avoid necrosis of the bone.

Sponsors & Collaborators

• Beirut Arab University

  lead OTHER

Principal Investigators

• Nayer Aboelsaad, Professor · Beirut Arab University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-12-03

Primary Completion

2023-10-10

Completion

2023-11-10

FDA Device

Yes

Countries

• Lebanon

Study Locations