Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation
Mandibular Ridge Augmentation Using Three-Dimensional Printed Model for Customization of Titanium Mesh
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2020
CompletedFirst Submitted
Initial submission to the registry
January 4, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2022
CompletedJanuary 20, 2022
January 1, 2022
7 months
January 4, 2022
January 14, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
Change in bone volume
Bone volume wa measured using CBCT
at baseline and 6 months
Operation time
Time of operation for each group will be calculated
During the procedure
Study Arms (2)
3D mandibular ridge augmentation
EXPERIMENTALConventional mandibular ridge augmentation
ACTIVE COMPARATORInterventions
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.
the conventional technique of ridge augmentation using Titanium Mesh
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Alexandria Faculty of Dentistry
Alexandria, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
January 4, 2022
First Posted
January 20, 2022
Study Start
October 1, 2019
Primary Completion
April 30, 2020
Study Completion
April 30, 2020
Last Updated
January 20, 2022
Record last verified: 2022-01