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OpenTrials
Completed

NCT Number: NCT05198011

Three-Dimensional Printed Customized Titanium Mesh for Mandibular Augmentation

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.

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Key information

Conditions

Alveolar Bone Loss Bone Diseases Bone Resorption Mouth Diseases Musculoskeletal Diseases Periodontal Atrophy Periodontal Diseases Stomatognathic Diseases

Age range

40 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria Faculty of Dentistry

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3D customized Titanium Mesh (Study)

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 ridge augmentation (Control)

Procedure

the conventional technique of ridge augmentation using Titanium Mesh

Primary outcomes

  1. Change in bone volume

    Time frame: at baseline and 6 months

    Bone volume wa measured using CBCT

  2. Operation time

    Time frame: During the procedure

    Time of operation for each group will be calculated

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jan 20, 2022
Registry last updated
Jan 20, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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