oral bone restoration
Conditions
Interventions
Trial Group:Magnesium-containing degradable polymer bone repair materials
Control group: Geistlich Bio-Oss Collagen
Sponsors
Beijing Chaoyang Hospital of Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age = 18 years old and = 65 years old, regardless of gender; (2) For the extraction of a single tooth with the reference of adjacent teeth, it is necessary to perform post-extraction site preservation surgery and oral bone restoration treatment; (3) There is a bone defect in the bone wall of the alveolar fossa of the affected tooth, and the vertical height of the bone wall with the largest bone defect is = 5mm with reference to the alveolar ridge of the adjacent tooth; (4) The bone wall of the alveolar fossa of the affected tooth should be at least one wall; (5) Subjects can understand the purpose of the study, show adequate compliance with the study protocol, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Alveolar bone defect caused by aggressive, malignant bone tumor; (2) Uncontrolled local infection at the proposed surgical site; (3) The adjacent tooth has uncontrolled periodontal disease, or there is impacted third molar distal in the second molar to be operated; (4) Those who need immediate missing tooth implant treatment; (5) History of bone grafting materials or magnesium allergy in the past; (6) Previous history of autoimmune disease or current autoimmune disease; (7) Combined with systemic infection, confirmed severe malnutrition, osteoporosis, severe heart disease or other vital organ failure; (8) Heavy smokers (smoking > 20 cigarettes/day); (9) Severe abnormal liver or kidney function (AST or ALT> 2 times the upper limit of normal; serum creatinine >1.5 times the upper limit of normal); (10) Patients with poorly controlled diabetes mellitus (fasting blood glucose = 8.88mmol/L or glycosylated hemoglobin =7%) after drug control); (11) Patients with poorly controlled hypertension (systolic blood pressure = 180mmHg and diastolic blood pressure =110mmHg after drug control); (12) Severe coagulation dysfunction (International Normalized Ratio INR>3.5); (13) Abnormal calcium/phosphorus/magnesium metabolism (blood calcium/phosphorus/magnesium beyond the normal range); (14) Hepatitis B/C/syphilis/HIV positive; (15) There are artifacts in the surgical area that can affect the oral imaging examination, such as metal dentures, porcelain teeth, etc.; (16) Patients who have used drugs that may affect or promote bone metabolism within 3 months prior to enrollment (including oral or injectable corticosteroids, various growth factors, non-steroidal anti-inflammatory drugs (except aspirin), sedative-hypnotic drugs, tetracyclines, bisphosphonates, or antibiotic drugs for more than 14 days); (17) Previous chemotherapy drugs or radiotherapy within 3 years prior to enrollment; (18) Participated in other interventional clinical trials within 1 month prior to enrollment; (19) Pregnant or lactating females; (20) Other situations in which the investigator believes that they should not participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Repair success rate at 24 weeks postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in alveolar ridge height at 12 and 24 weeks postoperatively;Change in alveolar ridge width at 12 and 24 weeks postoperatively ;Change in bone graft density score at 12 and 24 weeks postoperatively;Incidence of rejection;Changes in bone metabolism;Instrument operation satisfaction assessment; | — |
Countries
China
Contacts
Public ContactWang Zuomin
Beijing Chaoyang Hospital of Capital Medical University
Outcome results
None listed