An interventional study of Advanced intelligence drill and Traditional rotary instrument in Maxillary Sinus Floor Augmentation, sponsored by Beirut Arab University. Completed at 1 site in Lebanon. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-12.
Sponsored by Beirut Arab University · Not applicable, Interventional, and Treatment
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:
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:
This study hopes to advance surgical techniques for safer and more effective preparation for dental implants.
This study investigates a new technology designed to make dental procedures safer and more effective. Specifically, it focuses on a the lateral approach of Maxillary Sinus Floor Augmentation (MSFA), used to prepare the insufficient maxilla for dental implants in areas with low bone height. The study compares a traditional drilling method to an advanced intelligence drill to determine which is better at reducing complications and improving outcomes.
{Purpose of the Study}
The goal is to evaluate if the advanced intelligent drill can:
{Participants}
In the study, all participants presented with less than 5 mm of bone height in the posterior maxilla and in need of MSFA procedure using the lateral window approach.
All participants are healthy patients without major systemic diseases (like uncontrolled diabetes or recent cancer treatments) who need dental implants but have insufficient bone height in the upper jaw.
Participants with the following were excluded from the study:
{Study Methods}
Participants were split into two groups:
Group A: Traditional Drilling Group: Used a standard dental drill to prepare the bony window.
Group B: AI Drill Group: Used the new AI-powered drill that stops automatically when it touches the schneiderian membrane, reducing the chance of damage.
All procedures were done under local anesthesia, and patients were monitored closely before, during, and after surgery.
Clinical and Radiographic diagnosis of the cases were done following a precise protocol by the operator.
Pre-operative diagnosis and planning of all cases is fundamental to avoid intra- and post- operative complications. Many factors are to be evaluated during this time. A MSFA checklist is put in place.
All the procedures are achieved with the full knowledge and consent of the patient. A written informed consent is obtained for each patient included in this study.
{Surgery}
PRE-SURGICAL PHASE
Investigations and Primary Evaluation
SURGICAL PHASE
The surgery is performed by the same surgeon. Precautions are taken to operate in sterile conditions. All procedures are performed under local anesthesia (articaine 4% in combination with epinephrine).
Procedure:
POST-OPERATIVE CARE
FOLLOW UP
The maxillary implants are not to be placed until a 6-months healing time has elapsed. Thus, a follow up is done at 1 months, 3 months and 6 months after MSFA procedure. The bone level assessed and measured via CBCT imaging at 6 months post-operative.
Beirut Arab University is the lead sponsor of 16 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will undergo Maxillary Sinus Floor Augmentation (MSFA) using the traditional rotary drill. The procedure involves preparing the lateral window with a rose-head bur, ensuring precision and irrigation to minimize trauma. The traditional drill is widely used in clinical practice but requires significant skill to avoid complications like Schneiderian membrane perforation.
Device: Traditional rotary instrument
Participants in this arm will undergo MSFA using a newly designed AI-powered drill. This innovative drill automatically stops rotation upon detecting the Schneiderian membrane, reducing the risk of perforation. The intervention also includes the use of specialized hydraulic pressure to aid in membrane elevation and preparation of the lateral window for grafting. The AI drill aims to enhance precision, efficiency, and safety during the procedure.
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.
Also known as: OLA Kit
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.
Also known as: Rosehead Bur
Duration of the procedure
Duration of the procedure a stopwatch in minutes and seconds will be used to time in minutes and seconds the procedure from the beginning of anaesthesia injection until the last suture is done.
Time frame: From the beginning of anaesthesia injection until the last suture is done
Duration of Osteotomy/Window preparation
A stopwatch will be used to time in minutes and seconds from the moment the drilling starts the osteotomy preparation till the complete window is formed.
Time frame: from the moment the drilling starts the osteotomy preparation till the complete window is formed
Clinical Schneiderian membrane thickness
During surgery: clinically by the surgeon's visual assessment according to the membrane translucency (Clear Translucent or Thick) by Score 0 and 1
Time frame: immediately after osteotomy is done
Radiographic Schneiderian membrane thickness
Pre-operatively assessed by radiographic imaging (CBCT) in millimeters
Time frame: Pre-operative
Perforation of the Schneiderian membrane
Perforation of the Schneiderian membrane: It is measured by a periodontal probe in millimeters
Time frame: During the surgery immediately when perforation occurs
Excessive Bleeding
Assessed during the procedure (presence/abscence score)
Time frame: During the surgery when bleeding occurs
Manipulation of the Drill used
assess its ease of access intra-operatively (Easy: 1, Hard: 0)
Time frame: From the beginning of the drilling until end of drilling
Satisfaction of Drill to operator
Subjective assessment by giving a score 0 for not satisfied and 1 for satisfied
Time frame: from the beginning of the drilling until the end of the drilling
Baseline Residual Bone Height
Measured from CBCT in millimeters: from the most inferior border of the maxillary sinus to the alveolar crest in a sagittal direction
Time frame: Pre-operative
Post-operative Bone Volume Gain
Measured on the CBCT immediately after surgery in millimeters and again 6 months post-operative at the follow up
Time frame: immediately after surgery and at 6 months post-operative
Post-operative Water Height (WH) in the sinus
Measure in millimeters on the CBCT immediately after surgery
Time frame: Immediately after surgery
Plan to share: Yes — The following individual participant data will be shared for this clinical study: 1. Pre-Operative Assessments: * Cone Beam Computed Tomography (CBCT) measurements of residual bone height and Schneiderian membrane thickness. * Presence or absence of anatomical variations (e.g., bony septa, posterior superior alveolar artery). 2. Intraoperative Data: * Duration of procedure and window preparation time. * Incidence of Schneiderian membrane perforation. * Details of bleeding events (if any), including management approaches. 3. Postoperative Outcomes: * Graft volume and resorption rates. * Bone gain at the surgical site (immediate and at 6 months follow-up).
Supporting information: Sap, Csr
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Beirut Arab University