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.
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