Actively Recruiting
Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study
Led by Hospital of Stomatology, Sun Yat-Sen University · Updated on 2025-03-11
142
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
H
Hospital of Stomatology, Sun Yat-Sen University
Lead Sponsor
S
Southern Medical University, China
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of additive-manufactured personalized titanium mesh compared to traditional prefabricated titanium mesh in guided bone regeneration for patients with large alveolar bone defects. This randomized, single-blind, positive-controlled prospective study aims to assess both short-term and long-term outcomes, including safety and complications, with a follow-up period of two years after surgery. Participants will undergo guided bone regeneration surgery using either additive-manufactured personalized titanium mesh designed from preoperative CBCT data or prefabricated titanium mesh. Both types of mesh are used to secure bone substitutes with fixation screws during the bone grafting procedure. The study includes a positive control group receiving the prefabricated mesh for comparison. During the study, participants will receive clinical and radiographic examinations free of charge at multiple time points over two years. Researchers will measure osteogenesis efficiency at 6 months and monitor the incidence of titanium mesh exposure at intervals up to 2 years post-surgery. The study also involves analysis of risk factors related to the treatments and overall participant safety monitoring throughout the follow-up period.
CONDITIONS
Brief Title
Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients missing single or multiple teeth with moderate to severe bone defects in the edentulous area requiring complex guided bone regeneration (moderate defects: ridge width 1-3 mm; severe defects: ridge width 2 1 mm).
- Edentulous area edges within 1 mm surrounded by alveolar bone without adjacent tooth roots or nerve canals, allowing complete retention of the personalized titanium mesh edge.
- Apical edge of edentulous area within 2 mm surrounded by alveolar bone without nerve canals, permitting design of retention screws for the personalized titanium mesh.
- The patient or guardian agrees to participate and signs informed consent.
- Age between 18 and 60 years.
You will not qualify if you...
- Patients with complete edentulism.
- Patients with mild bone defects (ridge width greater than 3 mm).
- Acute or chronic infection in the surgical area.
- Acute or chronic infection in teeth adjacent to the edentulous area.
- Participation in similar or other interventional clinical trials within 30 days before consent.
- History of metal allergies, severe allergies, or severe immune deficiency.
- Uncontrolled metabolic diseases such as diabetes with poor control or severe liver/kidney dysfunction.
- Long-term use of steroid medications.
- History of drug abuse or alcoholism.
- Pregnant or breastfeeding women.
- Poor compliance.
- Other conditions judged unsuitable by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day or hospital stay as required
Participants undergo guided bone regeneration surgery using either additive-manufactured personalized titanium mesh or prefabricated titanium mesh to secure bone substitutes. Fixation screws are used to secure the titanium mesh during the surgery.
1 surgical visit and immediate post-operative care
Duration - Up to 2 years after surgery
Participants are monitored for bone healing and potential titanium mesh exposure at multiple timepoints after surgery.
Visits at 14 days, 1 month, 6 months, 1 year, and 2 years after surgery
Trial Site Locations
Total: 1 location
1
Hospital of Stomatology, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510030
Actively Recruiting
Research Team
J
Jiayun Xu
J
Jinming Wang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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