Clincosm LogoSign in Get a demo

Assessment of Vertical Ridge Augmentation for Posterior Mandible by Computer Guided Onlay vs Free Hand Onlay Graft

Sponsor
Cairo University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05512078
Collaborator
(none)
8
Enrollment
1
Location
2
Arms
20
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

for patients with vertical bone loss in posterior mandible area......invistigators use chin blocks for vertical augmentation...i compare between using guide for positiong the block with the desired position using special surgical guide versus position the block with free hand technique

Condition or Disease Intervention/Treatment Phase
  • Procedure: bone positioning surgical guide
 N/A

Detailed Description

• The CBCT scan images will be imported into a computer software (Mimics15, Materialise, Leuven, Belgium) for the reformatting of the retrieved DICOM images and reconstruction of three-dimensional virtual model of both the donor and recipient sites.

The virtual model will be imported into a second software (3-Matic, Materialise, Leuven, Belgium) specialized in designing medical devices and surgical stents.

  • The 1st surgical guide will be designed to guide the harvesting of two bilateral bone blocks ensuring that each block is designed with the superior osteotomy line more than 5 mm away from the apices of the anterior teeth and the inferior line more than 5 mm away from the inferior border of the mandible and the medial line 5 mm away from the symphysis, with two screw holes in the symphysis area to fixate the guide to the bone.

  • The 2nd surgical guide will be designed to guide the fixation of the onlay graft, the design will include two screw holes placed with minimum 2mm safety margin below the inferior alveolar canal to fixate the guide in place, and two more screw holes placed supracrestal to fixate the graft to the guide superiorly.

  • Finally, the surgical guide will be printed using fused deposition modeling technology with acrylonitrile butadiene styrene (ABS) plastic material. All guides will be sterilized using 2.4% gluteraldehyde for 12 hours prior to the surgery. All surgeries will be performed by the same surgeon.

Study Design

Study Type:
Interventional
Actual Enrollment :
8 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
patients with bilateral vertical bone loss in posterior mandiblepatients with bilateral vertical bone loss in posterior mandible
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Assessment of Vertical Ridge Augmentation for Posterior Mandible Using Computer Guided Onlay Versus Free Hand Onlay Grafting Procedures: A Randomized Clinical Split Mouth Trial
Actual Study Start Date :
Dec 1, 2020
Actual Primary Completion Date :
Dec 1, 2021
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention

patient specific surgical positioning guide

Procedure: bone positioning surgical guide
patient specific surgical positioning guide made from acrylonitrile butadiene styrene (ABS) plastic material.
Other Names:
  • bone fixation surgical guide

    		•
    Active Comparator: control

    onlay bone graft

    Procedure: bone positioning surgical guide
    patient specific surgical positioning guide made from acrylonitrile butadiene styrene (ABS) plastic material.
    Other Names:
  • bone fixation surgical guide

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Alveolar ridge vertical bone height [4months]

      measuring alveolar height bone gain using cbct

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 55 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Age range from 25-55 years. No sex predilection. 8

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

    • Edentulous bilateral posterior mandible with vertically deficient alveolar ridge that is less than 7mm measured from the crest of the alveolar ridge to the inferior alveolar canal.

    • Normal vertical dimension with normal inter-arch space.

    • The minimum number of missing teeth in the posterior mandible alveolar ridge is two adjacent posterior 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry Cairo Egypt 39828

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Hamid Khorshed, principle investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05512078
    Other Study ID Numbers:
    • omf10721
    First Posted:
    Aug 23, 2022
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Mahmoud Hamid Khorshed, principle investigator, Cairo University
    vertical posterior mandible

    Study Results

    No Results Posted as of Aug 23, 2022