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Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration
Sponsor: Hospital of Stomatology, Sun Yat-Sen University
Summary
This goal of this single-blind, simple randomized, positive-controlled prospective study is to evaluate the effects of additive-manufactured personalized titanium mesh and traditional titanium mesh in guided bone regeneration for large alveolar bone defects. The study will assess the short-term and long-term efficacy, safety, and incidence of complications of the additive-manufactured personalized titanium mesh, along with an analysis of risk factors. Participants will be followed up for two years after surgery with free-of-charge clinical and radiographic examinations.
Official title: Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study
Key Details
Gender
All
Age Range
18 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
142
Start Date
2024-11-30
Completion Date
2028-12
Last Updated
2025-03-11
Healthy Volunteers
No
Interventions
Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh
Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration.In the bone grafting surgery, the additive-manufactured personalized titanium mesh is used to secure the bone substitutes, with fixation screws used to secure the titanium mesh.
Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh
In bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh.
Locations (1)
Hospital of Stomatology, Sun Yat-Sen University
Guangzhou, Guangdong, China