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

NCT06692244 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2025-03-11

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Southern Medical University, China

    collaborator OTHER

  • Meizhou People's Hospital

    collaborator OTHER

  • Shenzhen Stomatology Hospital

    collaborator UNKNOWN

  • Guangzhou Medical University

    collaborator OTHER

  • Hospital of Stomatology, Sun Yat-Sen University

    lead OTHER

Principal Investigators

  • Jinming Wang · Hospital of Stomatology, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-11-30
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • China

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 NCT06692244 on ClinicalTrials.gov