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.
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.
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.
Parallel
Guided Bone Regeneration Surgery Using Additive-Manufactured Personalized Titanium Mesh
Procedure/SurgeryPreoperative 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.
Guided Bone Regeneration Surgery Using Prefabricated Titanium Mesh
Procedure/SurgeryIn 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.
Incidence of titanium mesh exposure
Record and observe the exposure of the titanium mesh during the healing process.
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Hospital of Stomatology, Sun Yat-Sen University
Lead sponsor
Southern Medical University, China
Collaborator
Meizhou People's Hospital
Collaborator
Shenzhen Stomatology Hospital
Collaborator
Guangzhou Medical University
Collaborator
