Repair of Bone Defects in Maxillofacial Surgery and Dental Surgery
Conditions
Interventions
Experimental Group:Participants in the experimental group will receive treatment with the bone graft material produced by Shandong Junxiu Biotechnology Co., Ltd. Investigators will perform oral bone g
Control Group:Participants in the control group will receive treatment with the bone graft material Geistlich Bio-Oss? Collagen (National Medical Device Import Registration No.: 20153170268), which is
Sponsors
Stomatological Hospital of Wuhan University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1.1 Study participants aged between 18 and 70 years (inclusive), regardless of gender; 1.2 Study participants who require bone material filling for buccal or lingual alveolar bone defects (with a defect height > 4 mm) due to maxillofacial surgery, oral surgery, periodontal surgery, implant surgery, or other relevant procedures; 1.3 Study participants with good follow-up compliance, who can attend scheduled re-examinations and follow-ups for 6 months; 1.4 Study participants who agree to participate in the study and voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 2.1 Study participants who are currently receiving or have received treatment with drugs that may affect or promote bone metabolism within 6 months; 2.2 Study participants who have taken bisphosphonates within 5 years; 2.3 Study participants with severe cardio-cerebrovascular diseases, or systemic diseases that may affect postoperative healing and/or osseointegration; 2.4 Study participants with systemic or local bone diseases, such as osteitis, bone tumors, bone tuberculosis, etc.; 2.5 Study participants with uncontrolled periodontal disease; 2.6 Study participants with uncontrolled metabolic diseases, such as diabetes mellitus, osteomalacia, thyroid diseases; 2.7 Study participants with acute or chronic infections in the surgical area (e.g., osteomyelitis); 2.8 Study participants with long-term use of adrenal cortical hormones; 2.9 Study participants with autoimmune diseases; 2.10 Study participants whose test results of alanine aminotransferase (ALT), aspartate aminotransferase (AST), creatinine (Cr), and urea exceed 2.5 times the upper limit of the normal range; 2.11 Study participants who are currently undergoing radiotherapy; 2.12 Study participants who have participated in other clinical trials of drugs or medical devices within 3 months; 2.13 Pregnant or lactating women, or study participants with plans for pregnancy within 6 months after the start of the trial; 2.14 Study participants whose ethnic beliefs prevent them from accepting the source of the trial device; 2.15 Study participants who are deemed inappropriate to participate in the trial by the researcher(s).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alveolar Bone Height Change Value; | — |
Secondary
| Measure | Time frame |
|---|---|
| Alveolar Bone Width Change Value;Wound Soft Tissue Healing Grading;Incidence Rate of Rejection Reaction; | — |
Countries
China
Contacts
Public ContactJihong Zhao
Stomatological Hospital of Wuhan University
Outcome results
None listed