Extraction socket filling, alveolar bone defect repair
Conditions
Interventions
Trial Group:Oral bone repair materials
Control Group:Geistlich Bio-Oss Collagen,Bilayer Collagen Membrane
Sponsors
The Third Affiliated Hospital of Air Force Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Male or female between 18 and 65 years of age (inclusive); 2. At least one adjacent tooth is extracted as a reference, and there is a bone defect on at least one side of the alveolar bone wall around the root of the affected tooth. Referring to the crest of the adjacent tooth's alveolar ridge, the height of the bone defect is >=5mm, requiring bone grafting (patients with non-completely impacted third molars that need to be extracted, and those with a bone defect distal to the adjacent tooth exceeding one-half of the tooth's root length); 3. Patients who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with abnormal liver or renal function (ALT, AST >2 × ULN, creatinine >1 × ULN); 2. Patients with coagulation dysfunction (APTT, PT >= 1.5 times the upper limit of normal) or those who have been taking oral anticoagulant drugs for a long time; 3. Patients with acute inflammation or tissue necrosis at the surgical site; 4. Periodontal and periapical diseases controlled by adjacent teeth; 5. The presence of adjacent teeth may lead to artifacts in the imaging examination of the surgical area (such as metal dentures or porcelain-fused-to-metal (PFM) teeth); 6. Those who are currently receiving or have received within the past 3 months medication that may affect bone metabolism (such as corticosteroids), or have previously used anti-bone resorption or anti-angiogenic drugs such as bisphosphonates or denosumab; 7. Patients with various bone defects caused by invasive and malignant bone tumors; 8. Those who suffer from severe cardiovascular and cerebrovascular diseases or severe hematological diseases (such as leukemia); 9. Uncontrolled metabolic diseases (such as diabetes with fasting blood glucose >=8.8 mmol/L or glycosylated hemoglobin >=7.0%, osteomalacia, thyroid disease, parathyroid disease, etc.); 10. Patients with a history of hypertension and poorly controlled condition that affects surgery (systolic blood pressure >=160 mmHg or diastolic blood pressure >=100 mmHg); 11. Individuals who are heavy smokers (smoking >=10 cigarettes per day), alcohol-dependent, or drug-addicted; 12. Those who have a history of radiotherapy or chemotherapy, or have received immunosuppressive therapy within half a year; 13. Those who are allergic to materials such as collagen, coral, and cellulose; 14. Individuals with mental disorders lacking behavioral autonomy (such as autism spectrum disorder, bipolar disorder, schizophrenia, depression, etc.); 15. Pregnant or lactating women, or those planning to become pregnant within half a year; 16. Participants who have participated in other clinical trials within 3 months; 17. Other situations where the researcher judges that the participant cannot participate in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The overall radiographic efficacy rate of alveolar ridge defect repair at 6 months post-surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| CBCT grayscale evaluation;Soft tissue morphometric evaluation;Evaluation of wound healing;Evaluation of satisfaction with equipment use; | — |
Countries
China
Contacts
Public ContactXue Yang
The Third Affiliated Hospital of Air Force Military Medical University
Outcome results
None listed