Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation

NCT ID: NCT05198011

Last Updated: 2022-01-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-01

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Alveolar Bone Loss

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3D mandibular ridge augmentation

Group Type EXPERIMENTAL

3D customized Titanium Mesh (Study)

Intervention Type PROCEDURE

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 mandibular ridge augmentation

Group Type ACTIVE_COMPARATOR

Conventional ridge augmentation (Control)

Intervention Type PROCEDURE

the conventional technique of ridge augmentation using Titanium Mesh

Interventions

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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.

Intervention Type PROCEDURE

Conventional ridge augmentation (Control)

the conventional technique of ridge augmentation using Titanium Mesh

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hams Hamed Abdelrahman

OTHER

Sponsor Role lead

Responsible Party

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Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Alexandria Faculty of Dentistry

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Augmentation_Maxillo

Identifier Type: -

Identifier Source: org_study_id

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