Reconstruction of Horizontal Ridge DefectsNCT07256730
Computer-Guided Ridge Split and Expansion Using an Electromagnetic Mallet
A study testing free-hand ridge splitting and AI/guided ridge splitting in people with Reconstruction of Horizontal Ridge Defects, run by Kafrelsheikh University at 1 site in Egypt.
Trial summary
The current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Reconstruction of Horizontal Ridge Defects
- 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
- 27 Aug 2024to 15 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 40 years of both sexes.
- 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 a minimum 3-month post-extraction healing period and a horizontal defect in the maxillary esthetic zone with at least a bone width of 3 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: Comparative Study Between Artificial Intelligence-Assisted/Computer-Guided Versus Conventional Ridge Splitting Utilizing Electromagnetic Mallet for Reconstruction of Horizontal Ridge Defects: A Randomized Controlled Clinical Study
The current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique.
Read the detailed description
Dental implants are a durable and long-term choice for tooth replacement to provide both functional and aesthetic benefits. However, successful implantation is critical, as it needs a sufficient amount of bone to maintain an ideal implant pathway and avoid vital structures. Vertical and horizontal ridge defects might occur after tooth extraction.
The pattern of alveolar ridge defect after extraction is classified according to the Cologne Classification into horizontal, vertical, combination, and sinus defects. mild (up to 4 mm), moderate (4-8 mm), and significant (over 8 mm) atrophy.
Successful implant placement is difficult to maintain with insufficient bone height and width. Many surgical techniques were introduced for the horizontally collapsed ridges, such as ridge augmentation, block graft, guided bone regeneration, and onlay graft. But these techniques need a long period of time for reconstruction, and an additional surgery is required for delayed implant placement.
Among these techniques, the ridge-splitting technique was performed for treating horizontally collapsed ridges by means of splitting the deficient ridge followed by ridge expansion to accommodate simultaneous implant placement.
The concept of the ridge-splitting technique is to make a self-space-making defect. The ridge-splitting technique was introduced by Tatum Jr. in 1986 and reintroduced in 1990 by Scipioni et al. In 1994, the technique was adapted by Summers, who utilized the viscoelastic properties of bone by applying pressure in-between buccal and lingual cortical bones using Summers osteotome to increase the width of the bone.
The ridge-splitting technique allowed the clinician to achieve desirable results within the shortest period and provide ridge expansion with simultaneous implant placement without the need for additional surgery and increase wound healing and satisfaction of the patient. Different instruments were used for splitting, such as chisels, discs, saws, osteomes, piezo surgery, and electromagnetic mallets.
The electromagnetic mallet consists of a handpiece that produces electromagnetic pulses with a rapid, non-impact motion that transmits to its tip, allowing high-intensity and precise movements with reduced trauma, minimal tissue damage, a greater safety margin, improved surgical outcomes, and faster recovery times. The precise movements make the repeatability of the procedure more applicable, which is very difficult to obtain with manual instruments.
Computer-guided surgery provides predictable and accurate treatment planning and implant positioning. It permits visualizing the jawbones and vital anatomical structures for preserving them during guided surgery. Artificial intelligence (AI) refers to the ability of machines to execute tasks that traditionally require human intelligence. Enhancing the high-quality dental treatment and precision of patient management, diagnosis, and treatment planning.
The current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique.
- Being tested
- free-hand ridge splitting, AI/guided ridge splitting
- Keywords
- ridge defects, ridge split, electromagnetic mallet, dental implant
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 a full-thickness flap. A midcrestal cut without vertical osteotomy will be done using electromagnetic mallet 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 the alveolar ridge guided by the guide slits. The cuts will be expanded progressively using bone wedges through the guide slits to 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 a torque wrench in a self-tapping fashion, engaging palatal and basal bone for primary stability.
| Study group | Role | What they receive |
|---|---|---|
| Freehand spit | Experimental | conventional ridge splitting with conventional simultaneous implant placement Receives: Procedure: free-hand ridge splitting |
| computer-guided split | 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 and at 6, 12 and 24months postoperatively
Measured: 24 months
Secondary outcomes (1)
vertical bone height
CBCT will be taken immediately after surgery and at 6, 12 and 24months postoperatively to evaluate vertical bone height.
Measured: 24months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study start27 Aug 2024
- Primary completion27 Aug 2026 (estimated)
- Study completion15 Sep 2026 (estimated)
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 Reconstruction of Horizontal Ridge DefectsStudies 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
- 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
- Investigators
- walid elamrousy, Study chair, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256730
- Sponsor's protocol ID
- KFSIRB200-338
- Status last verified
- Jul 2026
- First submitted
- 20 Nov 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elayah SA, Younis H, Cui H, Liang X, Sakran KA, Alkadasi B, Al-Moraissi EA, Albadani M, Al-Okad W, Tu J, Na S. Alveolar ridge preservation in post-extraction sockets using concentrated growth factors: a split-mouth, randomized, controlled clinical trial. Front Endocrinol (Lausanne). 2023 May 17;14:1163696. doi: 10.3389/fendo.2023.1163696. eCollection 2023.
PubMed 37265705
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between Artificial Intelligence-Assisted/Computer-Guided Versus Conventional Ridge Splitting Utilizing Electromagnetic Mallet for Reconstruction of Horizontal Ridge Defects: A Randomized Controlled Clinical Study
- ClinicalTrials.gov ID
- NCT07256730
- Acronym / sponsor ID
- KFSIRB200-338
- Keywords
- ridge defects, ridge split, electromagnetic mallet, dental implant
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Kafrelsheikh UniversityUniversity, hospital or other
- Study start
- 27 Aug 2024 (actual)
- Primary completion
- 27 Aug 2026 (estimated)
- Study completion
- 15 Sep 2026 (estimated)
- First posted
- 1 Dec 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 current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique.
Detailed description
Dental implants are a durable and long-term choice for tooth replacement to provide both functional and aesthetic benefits. However, successful implantation is critical, as it needs a sufficient amount of bone to maintain an ideal implant pathway and avoid vital structures. Vertical and horizontal ridge defects might occur after tooth extraction.
The pattern of alveolar ridge defect after extraction is classified according to the Cologne Classification into horizontal, vertical, combination, and sinus defects. mild (up to 4 mm), moderate (4-8 mm), and significant (over 8 mm) atrophy.
Successful implant placement is difficult to maintain with insufficient bone height and width. Many surgical techniques were introduced for the horizontally collapsed ridges, such as ridge augmentation, block graft, guided bone regeneration, and onlay graft. But these techniques need a long period of time for reconstruction, and an additional surgery is required for delayed implant placement.
Among these techniques, the ridge-splitting technique was performed for treating horizontally collapsed ridges by means of splitting the deficient ridge followed by ridge expansion to accommodate simultaneous implant placement.
The concept of the ridge-splitting technique is to make a self-space-making defect. The ridge-splitting technique was introduced by Tatum Jr. in 1986 and reintroduced in 1990 by Scipioni et al. In 1994, the technique was adapted by Summers, who utilized the viscoelastic properties of bone by applying pressure in-between buccal and lingual cortical bones using Summers osteotome to increase the width of the bone.
The ridge-splitting technique allowed the clinician to achieve desirable results within the shortest period and provide ridge expansion with simultaneous implant placement without the need for additional surgery and increase wound healing and satisfaction of the patient. Different instruments were used for splitting, such as chisels, discs, saws, osteomes, piezo surgery, and electromagnetic mallets.
The electromagnetic mallet consists of a handpiece that produces electromagnetic pulses with a rapid, non-impact motion that transmits to its tip, allowing high-intensity and precise movements with reduced trauma, minimal tissue damage, a greater safety margin, improved surgical outcomes, and faster recovery times. The precise movements make the repeatability of the procedure more applicable, which is very difficult to obtain with manual instruments.
Computer-guided surgery provides predictable and accurate treatment planning and implant positioning. It permits visualizing the jawbones and vital anatomical structures for preserving them during guided surgery. Artificial intelligence (AI) refers to the ability of machines to execute tasks that traditionally require human intelligence. Enhancing the high-quality dental treatment and precision of patient management, diagnosis, and treatment planning.
The current trial aims to assess the efficacy of utilizing the electromagnetic mallet either by AI-assisted digital workflow or by the conventional freehand approach for reconstruction of horizontal ridge defects utilizing the ridge-split and expansion technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Freehand spit | Experimental | Procedure: free-hand ridge splittingconventional ridge splitting with conventional simultaneous implant placement |
| computer-guided split | 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 (6 listed)
- The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
- Age ranges from 18 to 40 years of both sexes.
- 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.
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 a full-thickness flap. A midcrestal cut without vertical osteotomy will be done using electromagnetic mallet 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 | Freehand spit |
| 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 the alveolar ridge guided by the guide slits. The cuts will be expanded progressively using bone wedges through the guide slits to 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 a torque wrench in a self-tapping fashion, engaging palatal and basal bone for primary stability. | Procedure or surgery | computer-guided split |
Primary outcome
alveolar ridge width
Time frame: 24 months
CBCT will have taken immediately after surgery and at 6, 12 and 24months postoperatively
1 secondary outcome
vertical bone height
Time frame: 24months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2026.
- Results publication: PubMed 37265705Elayah SA, Younis H, Cui H, Liang X, Sakran KA, Alkadasi B, Al-Moraissi EA, Albadani M, Al-Okad W, Tu J, Na S. Alveolar ridge preservation in post-extraction sockets using concentrated growth factors: a split-mouth, randomized, controlled clinical trial. Front Endocrinol (Lausanne). 2023 May 17;14:1163696. doi: 10.3389/fendo.2023.1163696. eCollection 2023.
- Individual participant dataSharing planned: No
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.
walid elamrousy study chair
Kafrelsheikh University
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 Reconstruction of Horizontal Ridge Defects, 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 6 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: under way, not looking for participants, as of the sponsor's last update on 14 Jul 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?
This study is still under way. Results are not available in the source record yet.
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 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 NCT07256730, 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 14 Jul 2026.