Alveolar Bone ResorptionNCT06135506
Artificial Intelligence/Computer Guided Ridge Splitting for Treating Horizontal Ridge Defects
A study testing free-hand ridge splitting and AI/guided ridge splitting in people with Alveolar Bone Resorption and Dental Implant Failure Nos, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided ridge splitting approach assisted by artificial intelligence versus conventional approach combined with simultaneous implant Placement. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Alveolar Bone Resorption, Dental Implant Failure Nos
- What is being tested?
- free-hand ridge splitting and AI/guided ridge splitting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Dec 2023to 19 Jan 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
- The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
- Age ranges from 18-40 years of both sexes.
- No gender restrictions were considered for initial screening.
- Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.
- Adequate oral hygiene.
- Eligible participants should present good general health and agree to random assignment to any of the two parallel study groups.
- Participants had minimum 3 months as post extraction healing period and horizontal maxillary anterior ridge defects with at least bone width of 3 mm and bone height of 13 mm.
Who cannot join
- Vertical ridge defect.
- Undercut on the labial/buccal side.
- Thick cortical bone without cancellous bone inside.
- Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, allergy to the used medications, uncooperative individuals or those unable to attend the study follow-up appointments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence-Assisted/Computer Guided Ridge Splitting for the Treatment of Horizontal Ridge Defects With Simultaneous Guided Implant Placement: Randomized Controlled Clinical Study
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided ridge splitting approach assisted by artificial intelligence versus conventional approach combined with simultaneous implant Placement.
Read the detailed description
Ridge split technique is considered one of the successful horizontal bone augmentation procedures especially in maxilla for the management of horizontal ridge defects. This was adapted by Summers in 1994.
Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.
Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.
- Being tested
- free-hand ridge splitting, AI/guided ridge splitting
- Keywords
- Artificial intelligence, ridge splitting, computer-guided surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
free-hand ridge splittingProcedure or surgery
Midcrestal incision will be followed by reflection of full thickness flap. Midcrestal cut without vertical osteotomy will be done using piezosurgery unit, and then the cut will be extended deep to the implant length. The ridge will be expanded progressively using bone wedges. Dental implant fixtures will be placed stably with 1 mm minimal thickness of buccal bone plate. Surgical site will be completely closed, and wound edges will be sutured in a tension-free way.
AI/guided ridge splittingProcedure or surgery
The patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial buccal mucosa.
A midcrestal cut will be performed on the crest of alveolar ridge guided by the guide slits. The cuts will be expanded progressively using bone wedges through the guide slits gradually lateralize and expand the labial alveolar plate of bone, so the labial cortex will move through the intentionally created micro gap till it touches the fitting aspect of the patient specific guide. Implant drills will be inserted through the guiding holes in the surgical guide and the implant osteotomy sites will be prepared. Finally, implants will be inserted in the osteotomy sites using torque-wrench in a self-tapping fashion engaging palatal and basal bone for primary stability.
| Study group | Role | What they receive |
|---|---|---|
| control group | Experimental | conventional ridge splitting with conventional simultaneous implant placement. Receives: Procedure: free-hand ridge splitting |
| study group | Experimental | computer guided ridge splitting assisted by artificial intelligence with simultaneous computer guided implant placement. Receives: Procedure: AI/guided ridge splitting |
What is being measured
The primary outcome is the main question the study is designed to answer.
alveolar ridge width
CBCT will have taken immediately after surgery, at 6 and 9 months postoperatively to evaluate ridge width using OnDemand3D™ App-3D CBCT software.
The alveolar ridge width will be measured buccolingually in axial view 2 mm apical to the implant collar margin.
Measured: 24-month.
Secondary outcomes (1)
vertical bone height
CBCT will have taken immediately after surgery, at 6 and 9 months postoperatively to evaluate vertical bone height.
Mesiodistal vertical bone height will be measured using coronal view from a fixed anatomical landmark point to the mesial and distal marginal bone level. Moreover, sagittal view will be used to measure buccolingual vertical bone height extending from fixed anatomical reference point to the buccal and lingual alveolar crest. usinng CBCT
Measured: 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start15 Dec 2023
- Primary completion15 Jan 2026
- Study completion19 Jan 2026
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 Alveolar Bone ResorptionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, 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
- NCT06135506
- Sponsor's protocol ID
- KFSIRB200-74
- Status last verified
- Mar 2026
- First submitted
- 11 Nov 2023
- Last updated
- 17 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Allam A, Hatata N, Salem W, Elgarba BM, Aboushara MA, Abdelfattah MY, Elamrousy W. Maxillary anterior horizontal ridge reconstruction using computer-guided ridge split and expansion: A randomized clinical trial with a 2-year follow-up. J Dent. 2026 Nov;174:106886. doi: 10.1016/j.jdent.2026.106886. Epub 2026 Jul 8.
PubMed 42419681
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence-Assisted/Computer Guided Ridge Splitting for the Treatment of Horizontal Ridge Defects With Simultaneous Guided Implant Placement: Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06135506
- Acronym / sponsor ID
- KFSIRB200-74
- Keywords
- Artificial intelligence, ridge splitting, computer-guided surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 15 Dec 2023 (actual)
- Primary completion
- 15 Jan 2026 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 18 Nov 2023 (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.
Aim of the current randomized clinical trial is to evaluate and compare the effectiveness of computer-guided ridge splitting approach assisted by artificial intelligence versus conventional approach combined with simultaneous implant Placement.
Detailed description
Ridge split technique is considered one of the successful horizontal bone augmentation procedures especially in maxilla for the management of horizontal ridge defects. This was adapted by Summers in 1994.
Guided implant surgery was used in dental implant surgery to achieve accuracy and an overall predictability. Successful guided implant workflow depends on 3-dimensional image acquisition and precise model fabrication.
Artificial intelligence application in implant dentistry has ushered in a new era of precision and efficiency demonstrating improved implant survival rates and patient satisfaction and enhance the integration of technologies with digital workflows.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Experimental | Procedure: free-hand ridge splittingconventional ridge splitting with conventional simultaneous implant placement. |
| study group | Experimental | Procedure: AI/guided ridge splittingcomputer guided ridge splitting assisted by artificial intelligence with simultaneous computer guided implant placement. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
- Age ranges from 18-40 years of both sexes.
- No gender restrictions were considered for initial screening.
- Absence of any complicating systemic condition that may contraindicate surgical procedures and implant placement.
- Adequate oral hygiene.
Key exclusion criteria (4 listed)
- Vertical ridge defect.
- Undercut on the labial/buccal side.
- Thick cortical bone without cancellous bone inside.
- Uncontrolled systematic disorders as, diabetes mellitus, uncontrolled periodontal disease, history of head and neck radiotherapy, smokers, pregnancy, noncompliant patients, allergy to the used medications, uncooperative individuals or those unable to attend the study follow-up appointments.
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 ridge splittingMidcrestal incision will be followed by reflection of full thickness flap. Midcrestal cut without vertical osteotomy will be done using piezosurgery unit, and then the cut will be extended deep to the implant length. The ridge will be expanded progressively using bone wedges. Dental implant fixtures will be placed stably with 1 mm minimal thickness of buccal bone plate. Surgical site will be completely closed, and wound edges will be sutured in a tension-free way. | Procedure or surgery | control group |
| AI/guided ridge splittingThe patient specific guides will be placed and fixed by monocortical osteosynthesis screws at the pre-planned positions at the labial buccal mucosa. A midcrestal cut will be performed on the crest of alveolar ridge guided by the guide slits. The cuts will be expanded progressively using bone wedges through the guide slits gradually lateralize and expand the labial alveolar plate of bone, so the labial cortex will move through the intentionally created micro gap till it touches the fitting aspect of the patient specific guide. Implant drills will be inserted through the guiding holes in the surgical guide and the implant osteotomy sites will be prepared. Finally, implants will be inserted in the osteotomy sites using torque-wrench in a self-tapping fashion engaging palatal and basal bone for primary stability. | Procedure or surgery | study group |
Primary outcome
alveolar ridge width
Time frame: 24-month.
CBCT will have taken immediately after surgery, at 6 and 9 months postoperatively to evaluate ridge width using OnDemand3D™ App-3D CBCT software. The alveolar ridge width will be measured buccolingually in axial view 2 mm apical to the implant collar margin.
1 secondary outcome
vertical bone height
Time frame: 24-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 17 Mar 2026.
- Derived from this study: PubMed 42419681Allam A, Hatata N, Salem W, Elgarba BM, Aboushara MA, Abdelfattah MY, Elamrousy W. Maxillary anterior horizontal ridge reconstruction using computer-guided ridge split and expansion: A randomized clinical trial with a 2-year follow-up. J Dent. 2026 Nov;174:106886. doi: 10.1016/j.jdent.2026.106886. Epub 2026 Jul 8.
- 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 ridge splitting and AI/guided ridge splitting in people with Alveolar Bone Resorption and Dental Implant Failure Nos, 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 7 inclusion and 4 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 17 Mar 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?
alveolar ridge width (time frame: 24-month.). 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 NCT06135506, 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 17 Mar 2026.