Efficacy and Safety of Additive Manufacturing Personalized Titanium Mesh in Guided Bone Regeneration: a Randomized, Single-blind, Positive-controlled Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- Osteogenesis efficiency
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh (Procedure)
Prefabricated Titanium Mesh
Use prefabricated titanium mesh for guided bone regeneration.
干预措施: Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh (Procedure)
结局指标
主要结局
Osteogenesis efficiency
时间窗: 6 months after surgery
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.
次要结局
- Incidence of titanium mesh exposure(14 days, 1 month, 6 months, 1 year, and 2 years after surgery)
研究者
Wang Jinming
Chief Physician
Hospital of Stomatology, Sun Yat-Sen University