Clinical trial NCT06731569: Advanced Intelligence Driven Drill for Maxillary Sinus Augmentation in Patients with Severe Bone Loss
Official title: Evaluation of the Lateral Window Approach of Maxillary Sinus Floor Augmentation Using a Newly Designed Advanced Intelligence Drill: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Maxillary Sinus Floor Augmentation
Keywords: dental implant
Advanced intelligence drill
osteotomy
maxillary sinus floor augmentation
schneiderian membrane
perforation
Lead sponsor: Beirut Arab University
Sponsor class: OTHER
First posted: 2024-12-12
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: 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:

* Reduce the risk of Schneiderian membrane perforation
* Make the procedure (bony window opening) quicker and easier for both patients and dentists.
* Provide better conditions for bone graft site and for dental implants.

{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:

* Active sinus infections.
* Large cysts or tumors in the jaw.
* Recently had sinus surgeries.

{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

1. A proper diagnosis and subsequent proper case selection must be achieved. A clinical and radiographic treatment planning using a Cone Beam Computer Tomography (CBCT) is mandatory. This diagnostic tool is essential in this region to provide precision in the measurement of the residual bone height and its density. It also adds information about the anatomy of the maxillary sinus, the presence of any pathologies and the presence of a septa.
2. The residual bone level is measured from the CBCT: from the most inferior border of the maxillary sinus to the alveolar crest in a sagittal direction.
3. The Schneiderian membrane thickness is measured from the CBCT.

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:

* Raise a full thickness mucoperiosteal flap with vertical incision exposing the alveolar ridge and the lateral wall of the maxillary sinus
* Perform the lateral window osteotomy using a rose-head bur or A.I drill. In the procedure using the OLA kit: the osteotomy is initiated using the A.I drill followed by the aqua lifter connected to a disposable syringe which is indicated to infuse physiological saline of 1.0-1.5 cc to preliminarily lift the Schneiderian membrane.
* Carefully elevate the sinus membrane using the special hand instruments
* Carry the Valsalva maneuver to make sure the sinus membrane is fully elevated and has no perforations
* The sinus floor is augmented using xenograft through the lateral window to fill the sub antral space created then covered with a resorbable collagen membrane.
* The wound is sutured by 4/0 PGA sutures

POST-OPERATIVE CARE

* Antibiotic therapy (amoxicillin + clavulonic acid 1000 mg BID) is prescribed for the next 7 days along with Non-Steroidal Anti-Inflammatory Drug (NSAID) (Ibuprofen 400 mg BID) for 5 days for pain and swelling.
* The patient is advised not to brush the area or apply pressure by eating on it. He is also advised to avoid smoking, blowing their noise and other activities that may increase the sinus pressure for one week post operative.
* Sutures are removed 7 to 10 days after surgery.

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.

Eligibility criteria: Inclusion Criteria:

1. Participants who are free from any systemic disorders
2. Residual bone height ≤ 5 mm
3. Absence of any infections in the maxillary sinus to be treated.
4. Highly co-operative and motivated patients who follow the pre- and post- operative care instructions.
5. Adequate vertical space indicated for implant placement and subsequent prosthesis (minimum of 4-5 mm)

Exclusion Criteria:

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

Primary outcomes:
measure: Duration of the procedure
timeFrame: From the beginning of anaesthesia injection until the last suture is done
measure: Duration of Osteotomy/Window preparation
timeFrame: from the moment the drilling starts the osteotomy preparation till the complete window is formed
measure: Clinical Schneiderian membrane thickness
timeFrame: immediately after osteotomy is done
measure: Radiographic Schneiderian membrane thickness
timeFrame: Pre-operative
measure: Perforation of the Schneiderian membrane
timeFrame: During the surgery immediately when perforation occurs
Secondary outcomes:
measure: Excessive Bleeding
timeFrame: During the surgery when bleeding occurs
measure: Manipulation of the Drill used
timeFrame: From the beginning of the drilling until end of drilling
measure: Satisfaction of Drill to operator
timeFrame: from the beginning of the drilling until the end of the drilling
measure: Baseline Residual Bone Height
timeFrame: Pre-operative
measure: Post-operative Bone Volume Gain
timeFrame: immediately after surgery and at 6 months post-operative
measure: Post-operative Water Height (WH) in the sinus
timeFrame: Immediately after surgery
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: Beirut Arab University
Study officials:
affiliation: Beirut Arab University
name: Nayer Aboelsaad, Professor
role: STUDY_CHAIR
References: