Artificial Intelligence/Computer Guided Ridge Splitting for Treating Horizontal Ridge Defects

NCT06135506 | Completed DMC

• 1 other identifier: KFSIRB200-74
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Dental Implant Failure Nos; Alveolar Bone Resorption

Keywords

Artificial intelligence; ridge splitting; computer-guided surgery

Outcome Measures

Primary Outcomes (1)

• 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.

  24-month.

Secondary Outcomes (1)

• vertical bone height

  24-months

Study Arms (2)

control group

EXPERIMENTAL

conventional ridge splitting with conventional simultaneous implant placement.

Procedure: free-hand ridge splitting

study group

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 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.

control group

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 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

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 18-40 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.

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)

Walid Elamrousy

Kafr ash Shaykh, 76130, Egypt

Location

Study Design

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

Study Record Dates

• First Submitted: November 11, 2023
• First Posted: November 18, 2023
• Study Start: December 15, 2023
• Primary Completion: January 15, 2026
• Study Completion: January 19, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Locations

EG (1)