Alveolar bone site preservation after tooth extraction
Conditions
Interventions
Trial Group:Covering with an absorbable biofilm (XenoGide)
Control Group:Covering with an absorbable biofilm (Geistlich Bio-Gide)
Sponsors
West China School/Hospital of Stomatology Sichuan 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. Patients undergoing single-tooth extraction with normal alveolar ridge height on at least one adjacent tooth; 3. X-ray images show a bone defect in the alveolar bone wall of the affected tooth, with the maximum vertical height of the defect >=5 mm as assessed by the investigator; or, in cases of third molar extraction for various reasons, X-ray images show normal proximal mesial alveolar ridge height of the second molar and a distal mesial alveolar ridge defect >=5 mm as assessed by the investigator; 4. Patients who voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with osseous defects caused by invasive malignant bone tumors, acute infectious lesions, or active metabolic bone disease; 2. Patients with periodontal tissue inflammation in the acute stage; 3. Patients with osteomyelitis, osteoporosis, or osteomalacia; 4. Patients with cardiac disease classified as Class II or higher according to NYHA functional classification; 5. Patients with poorly controlled diabetes, defined as fasting plasma glucose >=8.0 mmol/L despite pharmacologic therapy; and patients with poorly controlled hypertension, defined as refractory hypertension (i.e., concurrent use of three distinct classes of antihypertensive agents—including a thiazide-type diuretic—for at least four weeks, each at the maximum labeled dose or the patient’s maximum tolerated dose, with office blood pressure remaining >=140/90 mmHg; or requiring >=4 antihypertensive agents to achieve target blood pressure); 6. Patients with a history of hyperparathyroidism that has not been adequately treated or is currently poorly controlled; 7. Participants with a known bleeding disorder or who are currently taking medications that affect coagulation (e.g., aspirin, clopidogrel, warfarin, heparin, etc.), or who have abnormal coagulation parameters (APTT or PT >1.5 × ULN); 8. Patients with abnormal liver or renal function (ALT, AST >2 × ULN, creatinine >1.5 × ULN), or serum calcium or phosphorus levels exceeding the normal reference range; 9. Patients with any condition in the target area that may cause artifacts in oral imaging (e.g., metal dentures, porcelain crowns, etc.); 10. Individuals with a known allergy to the investigational product or to materials or products derived from porcine or bovine sources; 11. Individuals who are habitual users of steroids (requiring routine treatment with high-dose corticosteroids); 12. Patients who are currently receiving or have received head and neck radiotherapy within 4 weeks prior to screening, or who have undergone chemotherapy for head and neck lesions during this same period; 13. Patients who are currently receiving or have received within 4 weeks prior to screening any medication that may affect or promote bone metabolism (including but not limited to glucocorticoids, antiepileptic drugs, aromatase inhibitors, gonadotropin-releasing hormone analogues, antiviral agents, thiazolidinediones, proton-pump inhibitors, and excess thyroid hormone); 14. Patients with a heavy smoking habit, defined as smoking more than 20 cigarettes per day; 15. Patients who cannot accept or are unwilling to receive any materials derived from porcine or bovine sources; 16. Individuals who have participated in any other clinical trial within the 4 weeks preceding screening, excluding non-interventional clinical trials; 17. Women of childbearing potential who test positive for pregnancy during screening; participants who have undergone irreversible sterilization (including hysterectomy, bilateral oophorectomy, or bilateral salpingectomy—but excluding bilateral tubal ligation) may be exempt from pregnancy testing; lactating women, or women planning pregnancy within the next six months, are also excluded; 18. Patients with any other condition that, in the investigator’s judgment, makes them unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Imageology diversity;Bone mineral density and integration of the bone graft material with the alveolar bone in follow-up cases;Alveolar ridge width and height; | — |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of participants with different wound healing statuses from surgery to day 14;Rejection reaction;Bone metabolism;Bone infection;Membrane rupture;Filler overflow;Re-implantation of bone;Changes in alveolar ridge width and height at 24 weeks postoperatively;Proportion of participants with different degrees of integration at 24 weeks postoperatively;Proportion of participants with bone graft density score >= immediate postoperative score at 24 weeks postoperatively; | — |
Countries
China
Contacts
Public ContactPan Jian
West China School/Hospital of Stomatology Sichuan University
Outcome results
None listed