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

NCT06691516 | Not Yet Recruiting

• 1 other identifier: Computer guided cortical shell
• Study Type: interventional
• Target: 22
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Bone Loss

Keywords

cortical shell , bone loss , computer guided

Outcome Measures

Primary Outcomes (1)

• accuracy of the implanted bone blocks

  * depening on the superimposition between immediate postoperative CBCT scan over planning * the maximum thickness of the implanted bone blocks (mimics)

  immediately post operative

Secondary Outcomes (1)

• bone gain vertical and horizontal

  6 months

Study Arms (2)

computer guide cortical shell technique in anterior mandible 3d defect

EXPERIMENTAL

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

Procedure: horizontal and vertical bone augmentation using computer guided cortical shell technique

free hand cortical shell technique in anterior 3d defect

ACTIVE COMPARATOR

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

Interventions

horizontal and vertical bone augmentation using computer guided cortical shell technique PROCEDURE

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

computer guide cortical shell technique in anterior mandible 3d defect

free hand cortical shell technique in anterior 3d defect PROCEDURE

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

free hand cortical shell technique in anterior 3d defect

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Intra-bony lesions (e.g., cysts) or infections (e.g., abscess) that may retard the osteotomy healing.
• Previous grafting procedures in the edentulous area

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Bone Diseases, Metabolic

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Ahmed Salah Ahmed Salah Sayed

CONTACT

+20 010207395; ahmed.ibrahem@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.Ahmed Salah

Study Record Dates

• First Submitted: November 14, 2024
• First Posted: November 15, 2024
• Study Start: November 21, 2024
• Primary Completion: December 26, 2025
• Study Completion: March 1, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11