Bone LossNCT06693921
Artificial Intelligence-Enhanced Three-Dimensional Reconstruction of Ridge Deficiencies
A study testing AI/guided block graft and AI/guided shell graft in people with Bone Loss, run by Kafrelsheikh University at 2 sites in Egypt.
Trial summary
n the current study, AI-assisted 3D ridge augmentation of combined vertical and horizontal deficient ridges utilizing allogenic dentin block versus allogenic dentin shell graft will be assessed. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss
- What is being tested?
- AI/guided block graft and AI/guided shell graft
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 2 sitesEgypt
- Study dates
- 17 Nov 2024to 30 Nov 2025
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Insufficient vertical and horizontal bone contour for dental implant placement in the maxillary esthetic zone.
- Volunteer for participating alveolar bone augmentation by allo-dentin graft technique.
- Absence of any complicating systemic condition that may contraindicate surgical procedures.
- Adequate oral hygiene.
Who cannot join
- Uncontrolled systematic disorders
- diabetes mellitus
- uncontrolled periodontal disease
- history of head and neck radiotherapy
- pregnancy
- noncompliant patients
- uncooperative individuals
- those unable to attend the study follow-up appointments
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Kafrelsheikh University
Kafr ash Shaykh, 42524
Walid Elamrousy
Kafr ash Shaykh, 76130
About this study
Official title: Artificial Intelligence-Enhanced Three-Dimensional Reconstruction of Combined Horizontal and Vertical Ridge Deficiencies Using Allogenic Dentin Block Versus Shell Tooth Graft Combined With Simultaneous Implant Placement
n the current study, AI-assisted 3D ridge augmentation of combined vertical and horizontal deficient ridges utilizing allogenic dentin block versus allogenic dentin shell graft will be assessed.
Read the detailed description
Severe periodontitis, trauma, and long-term edentulism can cause significant resorptive alterations of the alveolar ridge, leading to severe bone defects in the esthetic zone. Careful hard and soft tissue evaluation prior to implant surgery is important to restore proper function and esthetics. Horizontal, vertical, or combined ridge defects after extraction significantly influence dental implant placement and its long-term stability, as well as the final esthetics outcome.
Under natural conditions following a tooth extraction, the alveolar bone around the empty socket would undergo resorption and the alveolar ridge would recede in height and width. Besides leading to aesthetic and functional issues, the reduced bone volume would also cause insufficient support to the dental implant, causing the implant to become loose and unstable. For patients facing such issues, alveolar ridge augmentation is necessary to regenerate the bone tissue and restore the alveolar ridge so as to ensure the long-term stability of the implant.
Although a large number of alloplastic, allogenic or xenogenic bone substitute materials are available for reconstruction of the alveolar crest, the use of autogenous bone is still considered the gold standard. Autogenous bone has excellent osteoinductive, osteoconductive and osteogenetic characteristics; immunological reactions or the transmission of diseases can be safely avoided, and predictable augmentation results can be obtained.
For several years, the use of dentin as an alternative autogenous material for alveolar crest reconstruction and the grafting of bone deficits has been described and investigated in animal experiments and clinical studies. Dentin is a suitable grafting material because it is very similar to bone in its organic and inorganic composition. Similar to the alveolar bone, about 90% of the organic substance of dentin consists of type I collagen. Also, osteogenetically relevant structural proteins, such as osteocalcin, osteonectin, phosphoprotein and sialoprotein, can be found in dentin. Moreover, dentin contains osteogenetically active factors, including bone morphogenetic protein 2 (BMP-2), tissue growth factor-ß (TGF-ß) and insulin- like growth factor-2 (IGF-2). As in alveolar bone, the inorganic components of dentin consist of various calcium phosphates such as hydroxylapatite, ß-tricalcium phosphate, octacalcium phosphate and amorphous calcium phosphate. Compared with autogenous bone, the use of dentin offers the advantage of avoiding the harvesting procedure and the possible resulting donor site morbidity with promising clinical and histological results owing to its inherent osteoinductive and osteoconductive capacity. In comparison to autogenous bone block graft, dentin grafts also show significantly less resorption.
However, autogenous dentin graft has limitations despite its proven bone-formation capacity: dependence of the quantity on the number of teeth indicated for extraction and the condition of the extracted teeth, lack of a standard method to process autogenous dentin graft, and patient preference. Therefore, the application of dentin graft material from other individuals- allogeneic dentin graft-has been considered as an alternative autogenous dentin graft. Allo-dentin graft was conceptualized from the demineralized bone matrix, which was largely developed and defined for the bone induction principle, which states that a protein macromolecule in dentin and bone induces the differentiation of mesenchymal cells into osteoblasts; this was postulated by Urist in 1965. The Allo-dentin graft is a refined allograft that has osteoinductivity and has been clinically used since the 1980s. Very few studies have investigated the application of Allo-dentin graft as bone substitutes for bone graft surgery. The narrative review of revealed that Allo-dentin graft has demonstrated a great potential for osteoinductivity in extraskeletal sites, maximum clinical safety and efficacy without antigenicity nor provoked immunologic reactions.
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 a relative advantage of having a 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 of 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.
Segmenting organs and tissues to create 3-dimensional models is a useful technique for diagnosis, surgical planning, and simulation. This technique is also applicable to the planning of 3D-ridge augmentation, which plays a significant part in oral and maxillofacial surgery. Segmentation enables accurate measurement of the ridge volume, providing clinicians with quantitative insight into changes caused by cysts and tumors. In addition, accurately segmenting provides valuable guidance for clinicians when planning ridge augmentation during implant surgery. Although manual segmentation can be used for this purpose, it is time-consuming and dependent on the practitioner's experience due to high inter and intra-observer variability on CBCT images. While artificial intelligence (AI) segmentation is generally more successful and easier to perform than manual segmentation.
In the current study, AI-assisted 3D ridge augmentation of combined vertical and horizontal deficient ridges utilizing allogenic dentin block versus allogenic dentin shell graft will be assessed.
- Conditions
- Bone Loss
- Being tested
- AI/guided block graft, AI/guided shell graft
- Keywords
- deficient ridges, Artifitial intelligence, allograft, ridge reconstruction
- Medical subject headings
- Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI/guided block graftProcedure or surgery
The allo-dentin tooth graft will be prepared by placing a dentin block from extracted teeth in the trim template and trimming with round burs to the planned dimension under the guidance of the template.
AI/guided shell graftProcedure or surgery
The allo-dentin shell graft will be prepared by placing a dentin shell from extracted teeth in the trim template and trimming with round burs to the planned dimension under the guidance of the template
| Study group | Role | What they receive |
|---|---|---|
| allogenic dentin block | Experimental | Participants will receive allogenic dentin block for reconstruction of combined vertical and horizontal ridge defects with simultaneous implant placement in the maxillary esthetic zone. Receives: Procedure: AI/guided block graft |
| allogenic dentin shell | Experimental | Participants will receive allogenic dentin shell for reconstruction of combined vertical and horizontal ridge defects with simultaneous implant placement in the maxillary esthetic zone. Receives: Procedure: AI/guided shell graft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Horizontal buccolingual ridge width
Measuring the buccolingual width of the ridge will be carried out by calculating the distance between the outer boundaries of the palatal and facial bony plates horizontally at a distance 2 mms away from the implant shoulder apically using CBCT.
Measured: 12 months
Secondary outcomes (2)
Facial marginal bone level
Measuring the distance between the fixture shoulder and the facial bone plate crest vertically will be carried out at the fixture midline to determine the facial marginal bone level
Measured: 12 months
Peri-implant bone density
One mm areas of interest were traced 1.2 mm away from the fixture on the CBCT cross-sectional view, followed by counting threshold pixels inside this area to calculate the mean Peri-implant bone density.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2024
- Study start17 Nov 2024
- Primary completion20 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone LossStudies 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
- 22 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
- NCT06693921
- Sponsor's protocol ID
- KFSIRB200-312
- Status last verified
- Jan 2026
- First submitted
- 15 Nov 2024
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: data will not be shared
Publications
Elraee L, Abdel Gaber HK, Elsayed HH, Adel-Khattab D. Autogenous dentin block versus bone block for horizontal alveolar ridge augmentation and staged implant placement: A randomized controlled clinical trial including histologic assessment. Clin Oral Implants Res. 2022 Jul;33(7):723-734. doi: 10.1111/clr.13936. Epub 2022 May 13.
PubMed 35509125
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Enhanced Three-Dimensional Reconstruction of Combined Horizontal and Vertical Ridge Deficiencies Using Allogenic Dentin Block Versus Shell Tooth Graft Combined With Simultaneous Implant Placement
- ClinicalTrials.gov ID
- NCT06693921
- Acronym / sponsor ID
- KFSIRB200-312
- Conditions
- Bone Loss
- Keywords
- deficient ridges, Artifitial intelligence, allograft, ridge reconstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 20 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 19 Nov 2024 (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.
n the current study, AI-assisted 3D ridge augmentation of combined vertical and horizontal deficient ridges utilizing allogenic dentin block versus allogenic dentin shell graft will be assessed.
Detailed description
Severe periodontitis, trauma, and long-term edentulism can cause significant resorptive alterations of the alveolar ridge, leading to severe bone defects in the esthetic zone. Careful hard and soft tissue evaluation prior to implant surgery is important to restore proper function and esthetics. Horizontal, vertical, or combined ridge defects after extraction significantly influence dental implant placement and its long-term stability, as well as the final esthetics outcome.
Under natural conditions following a tooth extraction, the alveolar bone around the empty socket would undergo resorption and the alveolar ridge would recede in height and width. Besides leading to aesthetic and functional issues, the reduced bone volume would also cause insufficient support to the dental implant, causing the implant to become loose and unstable. For patients facing such issues, alveolar ridge augmentation is necessary to regenerate the bone tissue and restore the alveolar ridge so as to ensure the long-term stability of the implant.
Although a large number of alloplastic, allogenic or xenogenic bone substitute materials are available for reconstruction of the alveolar crest, the use of autogenous bone is still considered the gold standard. Autogenous bone has excellent osteoinductive, osteoconductive and osteogenetic characteristics; immunological reactions or the transmission of diseases can be safely avoided, and predictable augmentation results can be obtained.
For several years, the use of dentin as an alternative autogenous material for alveolar crest reconstruction and the grafting of bone deficits has been described and investigated in animal experiments and clinical studies. Dentin is a suitable grafting material because it is very similar to bone in its organic and inorganic composition. Similar to the alveolar bone, about 90% of the organic substance of dentin consists of type I collagen. Also, osteogenetically relevant structural proteins, such as osteocalcin, osteonectin, phosphoprotein and sialoprotein, can be found in dentin. Moreover, dentin contains osteogenetically active factors, including bone morphogenetic protein 2 (BMP-2), tissue growth factor-ß (TGF-ß) and insulin- like growth factor-2 (IGF-2). As in alveolar bone, the inorganic components of dentin consist of various calcium phosphates such as hydroxylapatite, ß-tricalcium phosphate, octacalcium phosphate and amorphous calcium phosphate. Compared with autogenous bone, the use of dentin offers the advantage of avoiding the harvesting procedure and the possible resulting donor site morbidity with promising clinical and histological results owing to its inherent osteoinductive and osteoconductive capacity. In comparison to autogenous bone block graft, dentin grafts also show significantly less resorption.
However, autogenous dentin graft has limitations despite its proven bone-formation capacity: dependence of the quantity on the number of teeth indicated for extraction and the condition of the extracted teeth, lack of a standard method to process autogenous dentin graft, and patient preference. Therefore, the application of dentin graft material from other individuals- allogeneic dentin graft-has been considered as an alternative autogenous dentin graft. Allo-dentin graft was conceptualized from the demineralized bone matrix, which was largely developed and defined for the bone induction principle, which states that a protein macromolecule in dentin and bone induces the differentiation of mesenchymal cells into osteoblasts; this was postulated by Urist in 1965. The Allo-dentin graft is a refined allograft that has osteoinductivity and has been clinically used since the 1980s. Very few studies have investigated the application of Allo-dentin graft as bone substitutes for bone graft surgery. The narrative review of revealed that Allo-dentin graft has demonstrated a great potential for osteoinductivity in extraskeletal sites, maximum clinical safety and efficacy without antigenicity nor provoked immunologic reactions.
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 a relative advantage of having a 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 of 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.
Segmenting organs and tissues to create 3-dimensional models is a useful technique for diagnosis, surgical planning, and simulation. This technique is also applicable to the planning of 3D-ridge augmentation, which plays a significant part in oral and maxillofacial surgery. Segmentation enables accurate measurement of the ridge volume, providing clinicians with quantitative insight into changes caused by cysts and tumors. In addition, accurately segmenting provides valuable guidance for clinicians when planning ridge augmentation during implant surgery. Although manual segmentation can be used for this purpose, it is time-consuming and dependent on the practitioner's experience due to high inter and intra-observer variability on CBCT images. While artificial intelligence (AI) segmentation is generally more successful and easier to perform than manual segmentation.
In the current study, AI-assisted 3D ridge augmentation of combined vertical and horizontal deficient ridges utilizing allogenic dentin block versus allogenic dentin shell graft will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| allogenic dentin block | Experimental | Procedure: AI/guided block graftParticipants will receive allogenic dentin block for reconstruction of combined vertical and horizontal ridge defects with simultaneous implant placement in the maxillary esthetic zone. |
| allogenic dentin shell | Experimental | Procedure: AI/guided shell graftParticipants will receive allogenic dentin shell for reconstruction of combined vertical and horizontal ridge defects with simultaneous implant placement in the maxillary esthetic zone. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Insufficient vertical and horizontal bone contour for dental implant placement in the maxillary esthetic zone.
Key exclusion criteria (8 listed)
- Uncontrolled systematic disorders
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 |
|---|---|---|
| AI/guided block graftThe allo-dentin tooth graft will be prepared by placing a dentin block from extracted teeth in the trim template and trimming with round burs to the planned dimension under the guidance of the template. | Procedure or surgery | allogenic dentin block |
| AI/guided shell graftThe allo-dentin shell graft will be prepared by placing a dentin shell from extracted teeth in the trim template and trimming with round burs to the planned dimension under the guidance of the template | Procedure or surgery | allogenic dentin shell |
Primary outcome
Horizontal buccolingual ridge width
Time frame: 12 months
Measuring the buccolingual width of the ridge will be carried out by calculating the distance between the outer boundaries of the palatal and facial bony plates horizontally at a distance 2 mms away from the implant shoulder apically using CBCT.
2 secondary outcomes
Facial marginal bone level
Time frame: 12 months
Peri-implant bone density
Time frame: 12 months
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 12 Jan 2026.
- Background: PubMed 35509125Elraee L, Abdel Gaber HK, Elsayed HH, Adel-Khattab D. Autogenous dentin block versus bone block for horizontal alveolar ridge augmentation and staged implant placement: A randomized controlled clinical trial including histologic assessment. Clin Oral Implants Res. 2022 Jul;33(7):723-734. doi: 10.1111/clr.13936. Epub 2022 May 13.
- Individual participant dataSharing planned: No. data will not be shared
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI/guided block graft and AI/guided shell graft in people with Bone Loss, run by Kafrelsheikh University at 2 sites 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 4 inclusion and 8 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 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Horizontal buccolingual ridge width (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06693921, which also lists 1 linked publication.
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 Jan 2026.