Maxillary Sinus DiseaseNCT06887582
Crestal Sinus Lifting in Periodontally-Compromised Patients Utilizing Autologous Dentin Graft
A study testing Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement, AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement and Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement in people with Maxillary Sinus Disease and Alveolar Bone Loss, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The integration of artificial intelligence and computer-guided technology offers the potential for improving surgical accuracy, reducing complications, and enhancing outcomes. Additionally, advancements such as electromagnetic mallets for bone manipulation and autologous dentin grafts provide promising alternatives… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Maxillary Sinus Disease, Alveolar Bone Loss
- What is being tested?
- Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement, AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement and Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteEgypt
- Study dates
- 21 Mar 2025to 10 Jul 2026
- 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 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Patients requiring sinus augmentation with insufficient bone height (4-7 mm).
- Indicated for single or multiple implant placements.
- No systemic contraindications for implant surgery.
Who cannot join
- • Severe sinus pathology (e.g., chronic sinusitis).
- History of radiation therapy in the maxillofacial region.
- Smokers
- Presence of acute (active) periapical infection.
- Large chronic periapical lesion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
faculty of dentistry, kafrelsheikh University
Kafr ash Shaykh, Kafrelsheikh, 214312
About this study
Official title: Artificial Intelligence-Assisted/Computer-Guided Crestal Sinus Lifting With Immediate Implant Placement in Periodontally-Compromised Patients Utilizing Electromagnetic Mallet and Autologous Dentin Block Graft: Randomized Clinical Trial
The integration of artificial intelligence and computer-guided technology offers the potential for improving surgical accuracy, reducing complications, and enhancing outcomes. Additionally, advancements such as electromagnetic mallets for bone manipulation and autologous dentin grafts provide promising alternatives for bone regeneration. This study aims to combine these technologies to assess the efficacy and clinical outcomes of AI-assisted, computer-guided crestal sinus lifting with immediate implant placement in periodontally compromised sites.
Read the detailed description
Implant therapy involving the posterior maxillary region in periodontally compromised patients may involve great difficulties due to the often severely reduced bone volume and the presence of a large maxillary sinus cavity. This problem is perpetuated in periodontally compromised patients. These unfavorable conditions are further compounded by the observations that osseointegration is less frequently achieved in the maxilla than the mandible, probably owing to the inferior quality of the bone in the posterior maxilla with its thin cortical bone layers and large cancellous structures. However, many clinical studies and case reports have been presented that describe methods for circumventing some of these problems through sinus membrane lift procedures, usually in conjunction with bone grafts of different types.
Bone grafts in conjunction with the placement of sinus implants are used to ensure the primary stability of the implant or to function as a scaffold for new bone formation by the host. In contrast, new bone around a sinus implant may be obtained following the placement of bone grafts. It might be expected that the mere lifting of the sinus membrane results in a void in which new bone formation would occur along the principles of guided bone regeneration.
Magneto-dynamic technology exploits the physical principles of electromagnetism to apply controlled forces on a body while minimizing the time of impact. The control and steadiness of the applied forces make the procedures safe for patients and surgeons. William Bonwill patented the first electrified dental mallet in 1873. In the 21st century, the Magnetic Mallet (MM) device exploits magneto-dynamic technology in dental surgery. The MM is composed of a handpiece energized by a power control device, delivering forces by the timing of application. Different inserts could be attached to the handpiece, which pushes a shock wave on its tip according to the surgical procedures. Four force modes are available: 75, 90, 130, and 260 daN. Several authors describe the application of MM in dental extractions, crestal sinus lift, ridge expansion, implant placement, and implant site preparation (osseodensification).
Cone beam computed tomography (CBCT) imaging developments went hand in hand with the increasing use of 3D imaging applications for presurgical planning and transfer of oral implant treatment. The main reasons for the triumph of CBCT are its capabilities of volumetric jaw bone imaging at reasonable costs and doses, with the relative advantage of having compact, affordable, and nearby equipment. For the clinicians involved in implant rehabilitation, the power of a dental 3D dataset is not only situated in the diagnostic field but also in the potential of gathering integrated patient information for presurgical and treatment applications related to oral implant placement. Nowadays, rapid advances in digital technology and computer-aided design/computer-aided manufacturing (CAD/CAM) systems are indeed creating challenging opportunities for diagnosis, surgical implant planning, and delivery of implant-supported prostheses.
Several studies used digital superimposition of optical impressions taken at different time points to assess the volumetric changes that occur after the sinus lifting technique. The rational beyond this was the higher accuracy and the less invasiveness of this assessment method.
Artificial intelligence (AI), a branch of computer science, is a fast-growing field in healthcare. The recent narrative review of Altalhi et al. in 2023, emphasized the integration and implications of AI in dental implantology. Authors concluded that AI's influence is unmistakable, enhancing treatment planning precision, enabling implant brand differentiation, fostering innovative implant designs with finite element analysis, and even venturing into outcome prediction and the promising realm of robotic-guided implant surgeries.
The integration of artificial intelligence (AI) and computer-guided technology offers the potential for improving surgical accuracy, reducing complications, and enhancing outcomes. Additionally, advancements such as electromagnetic mallets (EMMs) for bone manipulation and autologous dentin grafts provide promising alternatives for bone regeneration. This study aims to combine these technologies to assess the efficacy and clinical outcomes of AI-assisted, computer-guided crestal sinus lifting (CSL) with immediate implant placement in periodontally compromised sites.
- Conditions
- Maxillary Sinus Disease, Alveolar Bone Loss
- Being tested
- Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement, AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement, Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement, AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement.
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placementProcedure or surgery
The sinus will be lifted and augmented by particulate autologous dentin graft followed by simultaneous free-hand implant placement
AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placementProcedure or surgery
The sinus will be lifted and augmented by particulate autologous dentin graft followed by simultaneous implant placement. all the procedures will be computer-guided with assistance of artificial intelligence
Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placementProcedure or surgery
The sinus will be lifted and augmented by autologous block dentin graft followed by simultaneous free-hand implant placement
AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement.Procedure or surgery
The sinus will be lifted and augmented by autologous block dentin graft followed by simultaneous implant placement. all the procedures will be computer-guided with assistance of artificial intelligence
| Study group | Role | What they receive |
|---|---|---|
| study group I | Experimental | Free-hand crestal sinus lifting with particulate autologous dentin graft and free-hand implant placement Receives: Procedure: Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement |
| study group II | Experimental | AI-assisted/computer-guided crestal sinus lifting with particulate autologous dentin graft and computer-guided implant placement. Receives: Procedure: AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement |
| study group III | Experimental | Free-hand crestal sinus liftingwith autologous dentin block graft and free-hand immediate implant placement Receives: Procedure: Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement |
| study group IV | Experimental | AI-assisted/computer-guided crestal sinus liftingwith autologous dentin block graft and computer-guided immediate implant placement. Receives: Procedure: AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone gain
CBCT scans will be captured and the distance from the crestal bone to the sinus boundries will be measured
Measured: 12-month.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start21 Mar 2025
- Primary completion30 Jun 2026
- Study completion10 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Maxillary Sinus DiseaseStudies of the same condition, open and under way.
- More trials run by Kafrelsheikh UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kafrelsheikh University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Walid Elamrousy, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887582
- Sponsor's protocol ID
- KFSIRB200-475
- Status last verified
- Aug 2026
- First submitted
- 16 Mar 2025
- Last updated
- 11 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted/Computer-Guided Crestal Sinus Lifting With Immediate Implant Placement in Periodontally-Compromised Patients Utilizing Electromagnetic Mallet and Autologous Dentin Block Graft: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06887582
- Acronym / sponsor ID
- KFSIRB200-475
- Conditions
- Maxillary Sinus Disease, Alveolar Bone Loss
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 21 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (actual)
- Study completion
- 10 Jul 2026 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The integration of artificial intelligence and computer-guided technology offers the potential for improving surgical accuracy, reducing complications, and enhancing outcomes. Additionally, advancements such as electromagnetic mallets for bone manipulation and autologous dentin grafts provide promising alternatives for bone regeneration. This study aims to combine these technologies to assess the efficacy and clinical outcomes of AI-assisted, computer-guided crestal sinus lifting with immediate implant placement in periodontally compromised sites.
Detailed description
Implant therapy involving the posterior maxillary region in periodontally compromised patients may involve great difficulties due to the often severely reduced bone volume and the presence of a large maxillary sinus cavity. This problem is perpetuated in periodontally compromised patients. These unfavorable conditions are further compounded by the observations that osseointegration is less frequently achieved in the maxilla than the mandible, probably owing to the inferior quality of the bone in the posterior maxilla with its thin cortical bone layers and large cancellous structures. However, many clinical studies and case reports have been presented that describe methods for circumventing some of these problems through sinus membrane lift procedures, usually in conjunction with bone grafts of different types.
Bone grafts in conjunction with the placement of sinus implants are used to ensure the primary stability of the implant or to function as a scaffold for new bone formation by the host. In contrast, new bone around a sinus implant may be obtained following the placement of bone grafts. It might be expected that the mere lifting of the sinus membrane results in a void in which new bone formation would occur along the principles of guided bone regeneration.
Magneto-dynamic technology exploits the physical principles of electromagnetism to apply controlled forces on a body while minimizing the time of impact. The control and steadiness of the applied forces make the procedures safe for patients and surgeons. William Bonwill patented the first electrified dental mallet in 1873. In the 21st century, the Magnetic Mallet (MM) device exploits magneto-dynamic technology in dental surgery. The MM is composed of a handpiece energized by a power control device, delivering forces by the timing of application. Different inserts could be attached to the handpiece, which pushes a shock wave on its tip according to the surgical procedures. Four force modes are available: 75, 90, 130, and 260 daN. Several authors describe the application of MM in dental extractions, crestal sinus lift, ridge expansion, implant placement, and implant site preparation (osseodensification).
Cone beam computed tomography (CBCT) imaging developments went hand in hand with the increasing use of 3D imaging applications for presurgical planning and transfer of oral implant treatment. The main reasons for the triumph of CBCT are its capabilities of volumetric jaw bone imaging at reasonable costs and doses, with the relative advantage of having compact, affordable, and nearby equipment. For the clinicians involved in implant rehabilitation, the power of a dental 3D dataset is not only situated in the diagnostic field but also in the potential of gathering integrated patient information for presurgical and treatment applications related to oral implant placement. Nowadays, rapid advances in digital technology and computer-aided design/computer-aided manufacturing (CAD/CAM) systems are indeed creating challenging opportunities for diagnosis, surgical implant planning, and delivery of implant-supported prostheses.
Several studies used digital superimposition of optical impressions taken at different time points to assess the volumetric changes that occur after the sinus lifting technique. The rational beyond this was the higher accuracy and the less invasiveness of this assessment method.
Artificial intelligence (AI), a branch of computer science, is a fast-growing field in healthcare. The recent narrative review of Altalhi et al. in 2023, emphasized the integration and implications of AI in dental implantology. Authors concluded that AI's influence is unmistakable, enhancing treatment planning precision, enabling implant brand differentiation, fostering innovative implant designs with finite element analysis, and even venturing into outcome prediction and the promising realm of robotic-guided implant surgeries.
The integration of artificial intelligence (AI) and computer-guided technology offers the potential for improving surgical accuracy, reducing complications, and enhancing outcomes. Additionally, advancements such as electromagnetic mallets (EMMs) for bone manipulation and autologous dentin grafts provide promising alternatives for bone regeneration. This study aims to combine these technologies to assess the efficacy and clinical outcomes of AI-assisted, computer-guided crestal sinus lifting (CSL) with immediate implant placement in periodontally compromised sites.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| study group I | Experimental | Procedure: Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placementFree-hand crestal sinus lifting with particulate autologous dentin graft and free-hand implant placement |
| study group II | Experimental | Procedure: AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placementAI-assisted/computer-guided crestal sinus lifting with particulate autologous dentin graft and computer-guided implant placement. |
| study group III | Experimental | Procedure: Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placementFree-hand crestal sinus liftingwith autologous dentin block graft and free-hand immediate implant placement |
| study group IV | Experimental | Procedure: AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement.AI-assisted/computer-guided crestal sinus liftingwith autologous dentin block graft and computer-guided immediate implant placement. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- • Patients requiring sinus augmentation with insufficient bone height (4-7 mm).
Key exclusion criteria (5 listed)
- • Severe sinus pathology (e.g., chronic sinusitis).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placementThe sinus will be lifted and augmented by particulate autologous dentin graft followed by simultaneous free-hand implant placement | Procedure or surgery | study group I |
| AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placementThe sinus will be lifted and augmented by particulate autologous dentin graft followed by simultaneous implant placement. all the procedures will be computer-guided with assistance of artificial intelligence | Procedure or surgery | study group II |
| Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placementThe sinus will be lifted and augmented by autologous block dentin graft followed by simultaneous free-hand implant placement | Procedure or surgery | study group III |
| AI-assisted/computer-guided sinus lift with autologous dentin block graft +computer-guided immediate implant placement.The sinus will be lifted and augmented by autologous block dentin graft followed by simultaneous implant placement. all the procedures will be computer-guided with assistance of artificial intelligence | Procedure or surgery | study group IV |
Primary outcome
Bone gain
Time frame: 12-month.
CBCT scans will be captured and the distance from the crestal bone to the sinus boundries will be measured
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Free-hand sinus lift augmanted by particulate autologous dentin graft + free-hand implant placement, AI-assisted/computer-guided sinus lift augmanted by particulate autologous dentin graft + computer-guided implant placement and Free-hand sinus lift with autologous dentin block graft +free-hand immediate implant placement in people with Maxillary Sinus Disease and Alveolar Bone Loss, run by Kafrelsheikh University at 1 site in Egypt.
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 3 inclusion and 5 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 11 Aug 2026. 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 Egypt. 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?
Bone gain (time frame: 12-month.). 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 11 Aug 2026.