Bone defect
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age: 18-65 (including 18 and 65), regardless of gender; 2. Patients who need to have a single tooth removed due to tooth disease, periodontal disease, root apical disease, tooth trauma, etc; 3. There are adjacent teeth on one or both sides of the affected teeth as a reference. The adjacent teeth have no uncontrolled dental pulp disease, no periodontal disease, No periodontal root disease, no tooth trauma, no root fracture, etc; 4. Before tooth extraction, the dental film (apical film) showed that there was bone defect in the bone wall of unilateral or multiple alveolar fossa around the root of the affected tooth. The height of bone defect was greater than 2mm with the alveolar crest of adjacent teeth as reference; 5. Patients who voluntarily participate in and sign the informed consent form and promise to follow up according to the plan.
Exclusion criteria
Exclusion criteria: 1. Participated in other clinical trials within 4 weeks before the start of this trial; 2. Various bone defects caused by invasive and malignant bone tumors; 3. The local defect height of the affected gingiva is = 3mm, and the absorbable biofilm cannot be wrapped, sutured and fixed; 4. Patients who are receiving or have received drugs that may affect or promote bone metabolism in recent 3 months; 5. Various bone defects caused by active infectious diseases and metabolic osteopathy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effective rate of alveolar bone defect repair 24 weeks after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes of alveolar bone graft density score 24 weeks after operation;Fusion rate of alveolar bone graft and alveolar bone wall 24 weeks after operation;Changes of alveolar ridge width and height in alveolar fossa 24 weeks after operation;Wound healing rate 12 ± 2 days after operation;Incidence of rejection from postoperative to 12 weeks;Changes in bone metabolism (changes in calcium and phosphorus electrolytes) from baseline to the end of the 12th week;Does the filling from postoperative to the end of 24 weeks affect the incidence of denture repair;Incidence of signs of bone infection from postoperative to the end of 24 weeks;The incidence of active bleeding in the operation area within 5 minutes after operation was observed; | — |
Countries
China
Contacts
Lixin (Shenzhen) Medical Instrument Co., Ltd