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NOT YET RECRUITING
NCT06942013
NA

Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation

Sponsor: Cairo University

View on ClinicalTrials.gov

Summary

The protocol outlines a randomized clinical trial comparing two surgical techniques for horizontal ridge augmentation in the anterior mandible: Computer-Guided Autogenous Cortical Shell Technique (using a patient-specific guide for precise placement). Free-Hand Autogenous Cortical Shell Technique (traditional approach without a guiding template). Key Points: The study aims to determine which method provides better accuracy and bone volume stability. Cone Beam CT scans (CBCT) will assess horizontal bone gain preoperatively and six months postoperatively. The trial is conducted at Cairo University's Faculty of Dentistry. Participants: Patients with pure horizontal bone loss in the anterior mandible. Outcomes: Primary: Bone width gain in millimeters. Secondary: Accuracy of augmentation and surgical time. Methodology: The study group will use computer-designed surgical osteotomy guides to harvest and place bone grafts with improved precision. The control group will rely on the conventional free-hand approach. Both groups will undergo bone grafting using autogenous cortical bone shells. Data Collection \& Analysis: Participants will be randomized and blinded. Data will be analyzed using statistical methods to compare effectiveness.

Official title: Radiographic Assessment of Cortical Shell Technique For Horizontal Ridge Augmentation In The Anterior Mandible Using Full Digital Workflow Versus Free Hand Protocol: A Randomized Clinical Trial

Key Details

Gender

All

Age Range

20 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2025-05-01

Completion Date

2026-09-01

Last Updated

2025-04-24

Healthy Volunteers

Yes

Interventions

DEVICE

Computer-Guided Autogenous Cortical Shell Technique (Study Group)

This study utilizes two patient-specific 3D-printed surgical guides to enhance precision in bone harvesting and fixation for horizontal ridge augmentation in the anterior mandible. Chin Harvesting Guide This tooth-supported guide is placed on the exposed mandibular symphysis to ensure accurate osteotomy cuts for harvesting a cortical bone shell. It directs piezo drill cuts (superior, inferior, and vertical) to minimize errors and prevent damage to vital structures. Bone Block Fixation Guide After harvesting, this guide helps in precise fixation of the cortical shell onto the recipient site. It includes pre-planned screw holes to ensure stable positioning of the graft and improve surgical accuracy. These guides enhance precision, reduce surgical time, and improve graft stability, making the computer-guided technique superior to the traditional free-hand method.

PROCEDURE

Free-Hand Autogenous Cortical Shell Technique (Control group)

In this group, horizontal ridge augmentation of the anterior mandible is performed using a free-hand technique without computer-guided assistance. Autogenous cortical bone is harvested from the mandibular symphysis using a conventional osteotomy performed manually. The harvested cortical shell is adapted and fixated at the recipient site using titanium mini screws, based on the surgeon's clinical judgment and intraoperative assessment. Bone particulate grafting using a 1:1 ratio of autogenous bone and xenograft material is packed into the defect to enhance volume stability. This approach may result in increased variability in graft positioning, longer surgical time, and higher dependence on surgeon experience.