Back to resultsThree-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
3D customized Titanium Mesh (Study)
Conventional ridge augmentation (Control)
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
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
Sites / Locations
- Alexandria Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
3D mandibular ridge augmentation
Conventional mandibular ridge augmentation
Arm Description
Outcomes
Primary Outcome Measures
Change in bone volume
Bone volume wa measured using CBCT
Operation time
Time of operation for each group will be calculated
Secondary Outcome Measures
Full Information
NCT ID
NCT05198011
First Posted
January 4, 2022
Last Updated
January 14, 2022
Sponsor
Hams Hamed Abdelrahman
1. Study Identification
Unique Protocol Identification Number
NCT05198011
Brief Title
Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation
Official Title
Mandibular Ridge Augmentation Using Three-Dimensional Printed Model for Customization of Titanium Mesh
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3D mandibular ridge augmentation
Arm Type
Experimental
Arm Title
Conventional mandibular ridge augmentation
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
3D customized Titanium Mesh (Study)
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Conventional ridge augmentation (Control)
Intervention Description
the conventional technique of ridge augmentation using Titanium Mesh
Primary Outcome Measure Information:
Title
Change in bone volume
Description
Bone volume wa measured using CBCT
Time Frame
at baseline and 6 months
Title
Operation time
Description
Time of operation for each group will be calculated
Time Frame
During the procedure
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Alexandria Faculty of Dentistry
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Learn more about this trial
Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation
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