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NCT05198011 Clinical Trial

Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation

Alveolar Bone Loss Clinical Trial

Official title:
Mandibular Ridge Augmentation Using Three-Dimensional Printed Model for Customization of Titanium Mesh

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05198011
Other study ID # Augmentation_Maxillo
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 1, 2019
Est. completion date April 30, 2020

Study information
Verified date January 2022
Source Alexandria University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Completely or partially edentulous patients suffer from resorption of the alveolar bone, they always seek rehabilitation which becomes challenging. Alveolar ridge augmentation is widely done now to offer these patients functional and esthetic restoration. Many techniques have been proposed to obtain good results of ridge augmentation. Titanium Mesh (TiMe) is widely used, also digital and computer-guided surgery now plays an important role to improve the techniques and results in ridge augmentation procedures.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date April 30, 2020
Est. primary completion date April 30, 2020
Accepts healthy volunteers No
Gender All
Age group 40 Years to 60 Years
Eligibility Inclusion Criteria: - Patients will have a posterior mandibular atrophic ridge - Distance between the crest of the ridge and the superior border of the inferior alveolar canal will be from 5 mm to 7 m - Adequate inter-arch space Exclusion Criteria: - Patients who have any uncontrolled systemic disease contraindicated to oral surgery ( Diabetes, hypertension, and patients under chemotherapy treatment ) - Patients who have any relevant bone disease. - Patients who are smokers

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• 3D customized Titanium Mesh (Study)
approach for planning and augmenting atrophic posterior mandibular ridge using a pre-customized TiMe on a 3D model. The 3D surgical model will be virtually created from a cone-beam computed tomography (CBCT) and printed using Fused deposition modeling (FDM) machine. The 3D model will be then used to contour the TiMe in accordance with the needed amount of augmentation then will be used to help pack and contour the graft material.
• Conventional ridge augmentation (Control)
the conventional technique of ridge augmentation using Titanium Mesh

Locations
Country Name City State
Egypt Alexandria Faculty of Dentistry Alexandria

Sponsors (1)
Lead Sponsor Collaborator
Hams Hamed Abdelrahman

Country where clinical trial is conducted

Egypt, 

Outcome
Type Measure Description Time frame Safety issue
Primary Change in bone volume Bone volume wa measured using CBCT at baseline and 6 months
Primary Operation time Time of operation for each group will be calculated During the procedure
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