An interventional study of Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh and Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh in Alveolar Bone Atrophy and Guided Bone Regeneration, sponsored by Hospital of Stomatology, Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-03-11.
Sponsored by Hospital of Stomatology, Sun Yat-Sen University · Not applicable, Interventional, and Treatment
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.
297 studies on the registry are indexed under Alveolar Bone Loss; 76 are open to participants now.
This study's planned enrollment of 142 is above the median of 25 across 254 interventional studies indexed under Alveolar Bone Loss.
Browse Alveolar Bone Loss studies →Hospital of Stomatology, Sun Yat-Sen University is the lead sponsor of 3 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Preoperative CBCT datas of participants are obtained to design and manufacture personalized titanium meshes.Use additive-manufactured personalized titanium meshes for guided bone regeneration.
Procedure: Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh
Use prefabricated titanium mesh for guided bone regeneration.
Procedure: Guided Bone Regeneration Surgery Using Prefabricated 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.
In bone grafting surgery, prefabricated titanium mesh is used to fix the bone substitutes, and fixation screws are used to secure the titanium mesh.
Osteogenesis efficiency
Based on the oral CBCT imaging data, bone volume is reconstructed for preoperative, the day of surgery, and six months after surgery. Bone volume changes are assessed by using mimics as the bone resorption rate. The bone formation effectiveness is evaluated based on the bone resorption rate.
Time frame: 6 months after surgery
Incidence of titanium mesh exposure
Record and observe the exposure of the titanium mesh during the healing process.
Time frame: 14 days, 1 month, 6 months, 1 year, and 2 years after surgery
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Hospital of Stomatology, Sun Yat-Sen University