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

Not Applicable

Completed

• Conditions: Dental Implant Failure Nos; Alveolar Bone Resorption
• Interventions: Procedure: free-hand ridge splitting; Procedure: AI/guided ridge splitting

• Registration Number: NCT06135506
• Lead Sponsor: Kafrelsheikh University

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.

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 Timeline

• Study First Submitted: 2023-11-11
• Study First Submitted QC: 2023-11-15
• Study First Posted: 2023-11-18
• Study Start: 2023-12-15
• Primary Completion: 2025-02-15
• Status Verified: 2025-03
• Study Completion: 2025-03-15
• Last Update Submitted: 2025-03-16
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• The target population with inadequate bone volume for implant placement due to width insufficiency of maxillary anterior alveolar ridges.
• Age ranges from 25-40 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	free-hand ridge splitting	conventional ridge splitting with conventional simultaneous implant placement.
study group	AI/guided ridge splitting	computer guided ridge splitting assisted by artificial intelligence with simultaneous computer guided implant placement.

Primary Outcome Measures

Name	Time	Method
alveolar ridge width	9-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.

Secondary Outcome Measures

Name	Time	Method
vertical bone height	9-months	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

Trial Locations

Locations (1)

Walid Elamrousy; 🇪🇬 Kafr Ash Shaykh, Egypt