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Maxillary Sinus Floor AugmentationNCT06731569

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

A study testing Advanced intelligence drill and Traditional rotary instrument in people with Maxillary Sinus Floor Augmentation, run by Beirut Arab University at 1 site in Lebanon.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Maxillary Sinus Floor Augmentation
What is being tested?
Advanced intelligence drill and Traditional rotary instrument
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteLebanon
Study dates
3 Dec 2022to 10 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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)

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Lebanon1 site
  • Beirut Arab University

    Beirut

Other trials in Lebanon

About this study

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 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.

Read more

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.

Read the 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.

Being tested
Advanced intelligence drill, Traditional rotary instrument
Keywords
dental implant, Advanced intelligence drill, osteotomy, maxillary sinus floor augmentation, schneiderian membrane, perforation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Advanced intelligence drillDevice

    Also called OLA Kit

    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.

  • Traditional rotary instrumentDevice

    Also called Rosehead Bur

    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.

Study groups in NCT06731569
Study groupRoleWhat they receive
Traditional rotary drill (Control Group)Active comparatorParticipants 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.
Receives: Device: Traditional rotary instrument
AI-powered drill (Intervention Group)ExperimentalParticipants 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.
Receives: Device: Advanced intelligence drill

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: From the beginning of anaesthesia injection until the last suture is done

  2. 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.

    Measured: from the moment the drilling starts the osteotomy preparation till the complete window is formed

  3. 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

    Measured: immediately after osteotomy is done

  4. Radiographic Schneiderian membrane thickness

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

    Measured: Pre-operative

  5. Perforation of the Schneiderian membrane

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

    Measured: During the surgery immediately when perforation occurs

Secondary outcomes (6)
  1. Excessive Bleeding

    Assessed during the procedure (presence/abscence score)

    Measured: During the surgery when bleeding occurs

  2. Manipulation of the Drill used

    assess its ease of access intra-operatively (Easy: 1, Hard: 0)

    Measured: From the beginning of the drilling until end of drilling

  3. Satisfaction of Drill to operator

    Subjective assessment by giving a score 0 for not satisfied and 1 for satisfied

    Measured: from the beginning of the drilling until the end of the drilling

  4. 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

    Measured: Pre-operative

  5. Post-operative Bone Volume Gain

    Measured on the CBCT immediately after surgery in millimeters and again 6 months post-operative at the follow up

    Measured: immediately after surgery and at 6 months post-operative

  6. Post-operative Water Height (WH) in the sinus

    Measure in millimeters on the CBCT immediately after surgery

    Measured: Immediately after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start3 Dec 2022
  3. Primary completion10 Oct 2023
  4. Study completion10 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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.
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06731569
Sponsor's protocol ID
2023-H-0126-D-M-0560
Status last verified
Dec 2023
First submitted
26 Nov 2024
Last updated
12 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
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).

Questions about this trial

What is this clinical trial studying?

A study testing Advanced intelligence drill and Traditional rotary instrument in people with Maxillary Sinus Floor Augmentation, run by Beirut Arab University at 1 site in Lebanon.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Lebanon. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Duration of the procedure (time frame: From the beginning of anaesthesia injection until the last suture is done). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2024.

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