Computer-Guided Ridge Split and Expansion Using an Electromagnetic Mallet

NCT07256730 | Recruiting DMC

• 1 other identifier: KFSIRB200-338
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Reconstruction of Horizontal Ridge Defects

Keywords

ridge defects; ridge split; electromagnetic mallet; dental implant

Outcome Measures

Primary Outcomes (1)

• alveolar ridge width

  CBCT will have taken immediately after surgery and at 6 and 12 months postoperatively

  12 months

Secondary Outcomes (1)

• vertical bone height

  12 months

Study Arms (2)

Freehand spit

EXPERIMENTAL

conventional ridge splitting with conventional simultaneous implant placement

Procedure: free-hand ridge splitting

computer-guided split

EXPERIMENTAL

computer-guided ridge splitting assisted by artificial intelligence with simultaneous computer-guided implant placement.

Procedure: AI/guided ridge splitting

Interventions

free-hand ridge splitting PROCEDURE

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.

Freehand spit

AI/guided ridge splitting PROCEDURE

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.

computer-guided split

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: lead

Study Sites (1)

Faculty of Dentistry, Periodontology Department

Kafr ash Shaykh, Egypt

RECRUITING

Related Publications (1)

• 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.

  PMID: 37265705 RESULT

Study Officials

• walid elamrousy

  Kafrelsheikh University

  STUDY CHAIR

Central Study Contacts

Asmaa Hamdy Elgarawany, Lecturer

CONTACT

+201229460097; asmaahady@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 20, 2025
• First Posted: December 1, 2025
• Study Start: August 27, 2024
• Primary Completion: February 11, 2026
• Study Completion: March 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)