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Guided Bone Regeneration With Customized Titanium Meshes

NCT04480073 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2020-07-21

No results posted yet for this study

Summary

The aims of this prospective clinical study are to evaluate: a) the effectiveness of digitally customized titanium meshes in association with autologous bone particles and bovine bone mineral and covered with collagen membranes for the regeneration of atrophic edentulous sites; b) the survival rate of implants placed in the reconstructed areas; and c) new bone regeneration from a histomorphometric point of view

Conditions

  • Bone Resorption

Interventions

PROCEDURE

Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges

Step one:1) exposure of atrophic areas; 2) bone harvesting from mandible or calvarium; 3) filling the meshes with a mixture of the autogenous bone and particulated xenograft in a 1:1 ratio; 4) stabilization of the mesh with titanium micro-screws. A post-operative cone-beam computed tomography (CBCT) will be done in all patients to have a reference point for the following controls. 6 months later, patients are re-evaluated with a new CBCT to check bone volumes of the regenerated tissues and to plan implant placement. Step two: 1) removal of the meshes; 2) preparation of implant sites (one of which will be randomly chosen to obtain a bone biopsy for histomorphometric analysis); 3) implant placement. 3 months later, implants will be uncovered and the prosthetic phases will start. Patients will be recalled 3, 6, and 12 months later, to assess peri-implant hard and soft tissue conditions, the stability of the reconstructed bone, and the onset of implant-related complications.

Sponsors & Collaborators

  • University of Milan

    lead OTHER

Principal Investigators

  • Matteo Chiapasco, Professor · Department of Biomedical, Surgical and Dental Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
19 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-01-10
Primary Completion
2021-12-30
Completion
2022-12-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04480073 on ClinicalTrials.gov