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

NCT ID: NCT06691516

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-21
• Study Completion Date: 2026-03-01

Brief Summary

• 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.

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.

Conditions

Bone Loss

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

computer guide cortical shell technique in anterior mandible 3d defect

in study group there are bone harvesting guide and two fixation guides

Group Type: EXPERIMENTAL

horizontal and vertical bone augmentation using computer guided cortical shell technique

Intervention Type: PROCEDURE

Computer-guided cortical shell technique in anterior mandible 3d defect using bone harvesting guide and fixation guides

free hand cortical shell technique in anterior 3d defect

in control group, the bone harvesting and shells fixation will done with free hand technique

Group Type: ACTIVE_COMPARATOR

free hand cortical shell technique in anterior 3d defect

Intervention Type: PROCEDURE

vertical and horizontal ridge augmentation in anterior mandible using free hand cortical shell technique

Interventions

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

Intervention Type: PROCEDURE

free hand cortical shell technique in anterior 3d defect

vertical and horizontal ridge augmentation in anterior mandible using free hand cortical shell technique

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Ahmed Salah Sayed Ibrahim Elballal

Dr.Ahmed Salah

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Ahmed Salah Ahmed Salah Sayed

Role: CONTACT

ahmed.ibrahem@dentistry.cu.edu.eg

+20 010207395

Other Identifiers

Computer guided cortical shell

Identifier Type: -

Identifier Source: org_study_id