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

NCT06731569 | Completed DMC FDA Device

• 1 other identifier: 2023-H-0126-D-M-0560
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dental implant; Advanced intelligence drill; osteotomy; maxillary sinus floor augmentation; schneiderian membrane; perforation

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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

  immediately after osteotomy is done

• Radiographic Schneiderian membrane thickness

  Pre-operatively assessed by radiographic imaging (CBCT) in millimeters

  Pre-operative

• Perforation of the Schneiderian membrane

  Perforation of the Schneiderian membrane: It is measured by a periodontal probe in millimeters

  During the surgery immediately when perforation occurs

Secondary Outcomes (6)

• Excessive Bleeding

  During the surgery when bleeding occurs

• Manipulation of the Drill used

  From the beginning of the drilling until end of drilling

• Satisfaction of Drill to operator

  from the beginning of the drilling until the end of the drilling

• Baseline Residual Bone Height

  Pre-operative

• Post-operative Bone Volume Gain

  immediately after surgery and at 6 months post-operative

Study Arms (2)

Traditional rotary drill (Control Group)

ACTIVE COMPARATOR

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

AI-powered drill (Intervention Group)

EXPERIMENTAL

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

Interventions

Advanced intelligence drill DEVICE

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

AI-powered drill (Intervention Group)

Traditional rotary instrument DEVICE

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

Traditional rotary drill (Control Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Participants with uncontrolled systemic conditions including Diabetes, Hypertension and Hyperthyroidism
• Participants currently undergoing chemotherapy or radiotherapy.
• Participants on current bisphosphonate therapy or on medication that could interfere with the sinus lift procedure.
• Presence of sinus infection
• Presence of a neoplasm or a large cyst of the sinus
• Participants who previously underwent a Caldwell-Luc surgery for the same Study Interventions

Sponsors & Collaborators

• Beirut Arab University: lead

Study Sites (1)

Beirut Arab University

Beirut, Lebanon

Location

Study Officials

• Nayer Aboelsaad, Professor

  Beirut Arab University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomly assigned to one of two groups, and each group receives a specific intervention: Group A: Traditional rotary drill. Group B: AI drill. Each group is treated independently, and the outcomes are compared at the end of the study.

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 12, 2024
• Study Start: December 3, 2022
• Primary Completion: October 10, 2023
• Study Completion: November 10, 2023
• Last Updated: December 12, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, CSR

Locations

LE (1)