MedTrace Logo

Radiographic Assessment of Guided Cortical Shell Technique for Horizontal Ridge Augmentation

NCT06942013 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-24

No results posted yet for this study

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.

Conditions

  • Horizontal Ridge Deficiency

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.

Sponsors & Collaborators

  • Cairo University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-05-01
Primary Completion
2026-05-01
Completion
2026-09-01

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06942013 on ClinicalTrials.gov