Advanced Intelligence Driven Drill for Maxillary Sinus Augmentation in Patients with Severe Bone … (NCT06731569) | Clinical Trial Compass
CompletedNot Applicable
Advanced Intelligence Driven Drill for Maxillary Sinus Augmentation in Patients with Severe Bone Loss
Lebanon12 participantsStarted 2022-12-03
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Participants who are free from any systemic disorders
. Residual bone height ≤ 5 mm
. Absence of any infections in the maxillary sinus to be treated.
. Highly co-operative and motivated patients who follow the pre- and post- operative care instructions.
. Adequate vertical space indicated for implant placement and subsequent prosthesis (minimum of 4-5 mm)
Exclusion criteria
. Participants with uncontrolled systemic conditions including Diabetes, Hypertension and Hyperthyroidism
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Duration of the procedure
Timeframe: From the beginning of anaesthesia injection until the last suture is done
2
Duration of Osteotomy/Window preparation
Timeframe: from the moment the drilling starts the osteotomy preparation till the complete window is formed
3
Clinical Schneiderian membrane thickness
Timeframe: immediately after osteotomy is done
4
Radiographic Schneiderian membrane thickness
Timeframe: Pre-operative
5
Perforation of the Schneiderian membrane
Timeframe: During the surgery immediately when perforation occurs