NCT04480073

Guided Bone Regeneration With Customized Titanium Meshes

Customized CAD/CAM Titanium Meshes for the Guided Bone Regeneration of Severe Alveolar Ridge Defects: Preliminary Results of a Prospective Clinical Follow-up Study in Humans
University of Milan·ClinicalTrials.gov·procedureRecruiting
View on ClinicalTrials.gov
Study focus
Disease/Condition
Bone Resorption
Drug/Device/Intervention
Customized CAD-CAM Titanium Mesh (Y-xoss CBR® by Reoss -Filderstadt - Germany) for Guided Bone Regeneration of atrophic alveolar ridges
Study type
Interventional
Intervention type
procedure
Sponsor & location
Primary sponsor
University of Milan
Location
Milan, Italy
Timeline & enrollment
Phase
N/A
Start date
Jan 10, 2018
End date
Dec 30, 2022
Enrollment
24 participants
Primary outcome

Histomorphometric analysis of bone samples taken from the reconstructed sites: bone remodeling and mineralization levels,Histomorphometric analysis of bone samples taken from the reconstructed sites: Volumetric tissue fractions,Histomorphometric analysis of bone samples taken from the reconstructed sites: Neo-vascularization,Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Complication rate of the reconstructive procedure,Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Assessment of bone gain,Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Implant survival,Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Incidence of implant-related complications,Effectiveness of digitally customized titanium meshes in association with autografts and xenografts for bone regeneration in resorbed jaws: Peri-implant bone resorption

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

ICD-10 classifications
OsteolysisPathological resorption of teethBone donorPostsurgical malabsorption osteoporosisPostsurgical malabsorption osteoporosis with pathological fracture
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT04480073
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT04480073 through Pure Global AI's free database. This phase not specified trial is sponsored by University of Milan and is currently Recruiting. The study focuses on Bone Resorption. Target enrollment is 24 participants.

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