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

Inclusion criteria

• 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 ≤ 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, ensuring that retention screws for the personalized titanium mesh can be designed in this area.
• The patient and/or his/her guardian agrees to participate in this trial and signs the informed consent form.

Exclusion criteria

• 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 the teeth adjacent to the edentulous area.
• Participation in similar trials or other interventional clinical trials within 30 days prior to signing the informed consent form.
• History of metal allergies, severe allergy history, or severe immune deficiency.
• Uncontrolled metabolic diseases, such as Type 1 diabetes or Type 2 diabetes (HbA1c ≥ 7% or fasting blood glucose ≥ 7 mmol/L despite medication control), severe liver or kidney dysfunction (ALT, AST > 2 times the upper limit of normal, serum creatinine above the upper limit of normal).
• 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.