Actively Recruiting
Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration
Led by Hospital of Stomatology, Sun Yat-Sen University · Updated on 2025-03-11
142
Participants Needed
1
Research Sites
208 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
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
Official 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 bone defects: bone loss with residual alveolar ridge width between 1 mm and 3 mm; severe bone defects: bone loss with residual alveolar ridge width 64 1 mm).
- The edge of the edentulous area within 1 mm is alveolar bone, with no adjacent tooth roots or nerve canals, ensuring complete retention of the personalized titanium mesh edge.
- The apical edge of the edentulous area within 2 mm is alveolar bone, with no nerve canals, allowing design of retention screws for the personalized titanium mesh in this area.
- The patient and/or guardian agrees to participate and signs the informed consent form.
You will not qualify if you...
- Patients with edentulism.
- Patients with mild bone defects (residual alveolar ridge width greater than 3 mm).
- Presence of acute or chronic infection in the surgical area.
- Presence of acute or chronic infection in teeth adjacent to the edentulous area.
- Participation in similar or other interventional clinical trials within 30 days before signing the informed consent form.
- History of metal allergies, severe allergy history, or severe immune deficiency.
- Uncontrolled metabolic diseases such as Type 1 or Type 2 diabetes (HbA1c 65 7% or fasting blood glucose 65 7 mmol/L despite medication), severe liver or kidney dysfunction.
- Long-term use of steroid medications.
- History of drug abuse or alcoholism.
- Pregnant or breastfeeding women.
- Poor compliance.
- Other conditions deemed unsuitable for participation by the investigator.
AI-Screening
AI-Powered Screening
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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
CONTACT
J
Jinming Wang
CONTACT
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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