Alveolar bone / jaw defect
Conditions
Interventions
The experimental group:Filling and repair of alveolar bone / jaw defects with test articles
The control group:Filling and repair of alveolar bone / jaw defects with reference materials
Sponsors
School of Stomatology, The Fourth Military Medical University (FMMU)
Eligibility
Sex/Gender
Male
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-70 years (inclusive), regardless of gender; 2. The alveolar bone / jaw defects caused by various reasons need to be filled, such as site preservation, guided bone regeneration, etc; 3. If a single tooth needs to be removed due to tooth / periodontal / periapical diseases, there are adjacent teeth as a reference, and there are no uncontrolled periodontal / periapical diseases or other tooth diseases in the adjacent teeth disease; 4. Imaging examination showed that there were bone defects on one or more bone walls of the alveolar fossa of the affected teeth, and the height of bone defects was >= 3mm with reference to the top of the alveolar ridge of the adjacent teeth, so bone grafting was needed; Remarks: patients with incomplete impacted third molars that need to be extracted and the distal bone defect of adjacent teeth exceeds more than half of the root length. 5. Voluntarily participate in the clinical trial and sign the informed consent of the subjects.
Exclusion criteria
Exclusion criteria: 1. Patients with wound infection not effectively controlled; 2. Uncontrolled metabolic diseases, such as diabetes (fasting blood glucose >= 8.0mmol/L after drug control), rickets disease, thyroid disease; 3. Use or long-term (3 months) use of special drugs that may affect postoperative healing or bone union, such as glucocorticoids, bisphosphonates, etc.; 4. Abnormal liver function (ALT, AST >= 1.5 times the upper limit of normal value), renal function (Cr >= 1.5 times the upper limit of normal value), coagulation function (APTT >= 1.5 times the upper limit of normal value) with clinical significance; 5. Patients with a history of uncontrolled hypertension that affects surgery (systolic blood pressure >= 160mmHg and/or diastolic blood pressure >= 100mmHg); 6. Patients with malignant tumors; 7. Patients with systemic or local bone diseases, such as osteitis, bone tumors, bone tuberculosis, etc.; 8. Periodontitis is not effectively controlled in the remaining teeth; 9. Patients with oral mucosal diseases (recurrent oral ulcer, lichen planus, etc.) that have not been effectively controlled; 10. Those who have smoked more than 10 cigarettes a day in the past month or are dependent on alcohol or drugs; 11. Local gingival soft tissue atrophy or defect, root exposure >= 3mm, affecting bone filling/repair material retention; 12. Patients with previous allergy to sodium hyaluronate; 13. Persons without or with limited capacity for civil conduct, such as mentally ill persons; 14. Pregnant or lactating women who have planned a pregnancy during the trial; 15. Participants who participated in other clinical trials within 1 month before the launch of this study; 16. Participants considered inappropriate to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes of alveolar ridge height after operation;Changes of alveolar ridge width after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wound healing;Imaging changes after filling materials at the extraction site;Device performance;Incidence of rejection; | — |
Countries
China
Contacts
Public ContactHongzhi Zhou
School of Stomatology, The Fourth Military Medical University (FMMU)
Outcome results
None listed