Radiographic Assessment Of The Accuracy Of 3D Ridge Augmentation In Anterior Mandible Using Computer Guided Autogenous Cortical Shell Technique Versus Free Hand Technique

November 14, 2024 updated by: Ahmed Salah Sayed Ibrahim Elballal, Cairo University

* this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol.

the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement

  • also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
  • also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
  • also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

this study aims to evaluate accuracy of fixation of the bone shells by a calculated distance which is always a challenging step for inexperienced surgeons to fix a cortical shells at the ideal position in the conventional protocol.

the fixation guides used to make the shells precisely fixed at the proper position and angulation the problem is if it fixed with insufficient distance with proposed volume loss leads to totally insufficient volume gain for future implant placement

  • also to evaluate the efficacy of the CAD/CAM surgical guide during chin harvesting (harvesting guide ) procedure in reducing the risk of anatomical structure damage (mental neve) and patient morbidity with more accuracy compared with the standard technique and preserve the roots of the lower anterior teeth or any fracture to the inferior border of the mandible also allow to harvest the bone shells from the suitable area with cancellous bone which prevent bad split of the bone shells this trial versus free hand conventional cortical shell bone technique both harvested from symphysis area (chin),
  • also to evaluate thickness of implanted bone shells , the thickness should be enough to preserve the graft(autograft 50% and xenograft 50%) between the buccal and lingual bone shells
  • also aims to evaluate the vertical and horizontal bone augmentation achieved at the anterior mandible using computer-guided cortical shell bone technique.

Study Type

Interventional

Enrollment (Estimated)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ranges from 20-60 years. No sex predilection.

Patients free from any systemic conditions and bone metabolism diseases that might interfere with the surgical intervention, soft tissue or hard tissue healing.

Edentulous anterior mandible with a horizontally deficient alveolar ridge that is less than 3mm in width and with a vertically defect at least 3mm in height.

The minimum number of missing teeth in the anterior mandible alveolar ridge is two adjacent teeth.

Exclusion Criteria:

  • Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.

Previous grafting procedures in the edentulous area

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: computer guide cortical shell technique in anterior mandible 3d defect
in study group there are bone harvesting guide and two fixation guides
Procedure: horizontal and vertical bone augmentation using computer guided cortical shell technique
Computer-guided cortical shell technique in anterior mandible 3d defect using bone harvesting guide and fixation guides
Active Comparator: free hand cortical shell technique in anterior 3d defect
in control group, the bone harvesting and shells fixation will done with free hand technique
Procedure: free hand cortical shell technique in anterior 3d defect
vertical and horizontal ridge augmentation in anterior mandible using free hand cortical shell technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
accuracy of the implanted bone blocks
Time Frame: immediately post operative
  • depening on the superimposition between immediate postoperative CBCT scan over planning
  • the maximum thickness of the implanted bone blocks (mimics)
immediately post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
bone gain vertical and horizontal
Time Frame: 6 months
CBCT volumetric change of deficient alveolar ridge after augmentation
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 21, 2024

Primary Completion (Estimated)

December 26, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

November 14, 2024

First Submitted That Met QC Criteria

November 14, 2024

First Posted (Actual)

November 15, 2024

Study Record Updates

Last Update Posted (Actual)

November 15, 2024

Last Update Submitted That Met QC Criteria

November 14, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Computer guided cortical shell

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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