NCT06692244

Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration

Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (estimated)
• Sponsor: Hospital of Stomatology, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Alveolar Bone Atrophy
• Guided Bone Regeneration

Interventions

Type	Name	Description
PROCEDURE	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.
PROCEDURE	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.

Timeline

• Start date: 2024-11-30
• Primary completion: 2027-12-01
• Completion: 2028-12-01
• First posted: 2024-11-18
• Last updated: 2025-03-11

Locations

1 site across 1 country: China