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Clinical Trials/NCT06135506
NCT06135506
Completed
Not Applicable

Artificial Intelligence-Assisted/Computer Guided Ridge Splitting for the Treatment of Horizontal Ridge Defects With Simultaneous Guided Implant Placement: Randomized Controlled Clinical Study

Kafrelsheikh University1 site in 1 country22 target enrollmentDecember 15, 2023

Overview

Phase
Not Applicable
Intervention
free-hand ridge splitting
Conditions
Alveolar Bone Resorption
Sponsor
Kafrelsheikh University
Enrollment
22
Locations
1
Primary Endpoint
alveolar ridge width
Status
Completed
Last Updated
last month

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 15, 2023
End Date
January 19, 2026
Last Updated
last month
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Walid Elamrousy

Assistant Professor of periodontology

Kafrelsheikh University

Eligibility Criteria

Inclusion Criteria

  • 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.

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.

Arms & Interventions

control group

conventional ridge splitting with conventional simultaneous implant placement.

Intervention: free-hand ridge splitting

study group

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

Intervention: AI/guided ridge splitting

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • vertical bone height(24-months)

Study Sites (1)

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