Insufficient horizontal buccal alveolar bone volume in the dental implantation area with a single missing tooth
Conditions
Interventions
Experimental group:deproteinized bovine bone mineral material combined with thermo-sensitive hydroxybutyl chitosan + absorbable collagen biofilm
control group: 0.9% saline to moisten deproteinized bovine bone mineral matrix material + absorbable collagen biofilm
Sponsors
School of Stomatology, The Fourth Military Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients aged between 18 and 65 years, regardless of gender; 2. Patients with non-restorable single-tooth loss need dental implant restoration; 3. Patients with insufficient buccal horizontal bone width but capable of providing initial implant stability, or with a socket bone width >=3 mm; 4. Patients with >= 2mm of keratinized gingiva from the alveolar crest midline to the mucogingival junction; 5. Sufficient vertical height at the ridge for safe implantation of >=8 mm implants, or ridge height >=5 mm; 6. Patients willing to participate in this clinical trial, and able to sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients with uncontrolled periodontitis in adjacent teeth of the surgical area; 2. Patients with unresolved acute or chronic periapical periodontitis in adjacent teeth of the surgical area; 3. Patients with oral mucosal lesions (e.g., lichen planus, leukoplakia, etc.); 4. Patients with space-occupying lesions (including cysts, tumors, etc.) in adjacent teeth of the surgical area; 5. Patients with systemic diseases that may affect postoperative healing and osseointegration (e.g., poorly controlled diabetes with fasting blood glucose still >= 8.8 mmol/L after medication, osteoporosis, HIV infection); 6. Patients with infectious diseases (hepatitis B, hepatitis C, syphilis, HIV/AIDS, etc.); 7. Patients with heart disease (class II or higher cardiac functional diseases); 8. Patients with severe liver or kidney dysfunction or abnormalities (AST or ALT >=2.5 times the upper limit of normal); 9. Patients with a history of or undergoing radiation therapy or chemotherapy to the head and neck; 10. Patients currently or long-term taking medications that affect postoperative healing or osseointegration (e.g., bisphosphonates, calcitonin, hormone replacement therapy for menopause, etc.); 11. Patients with a history of drug addiction, alcoholism, substance abuse, or self-reported smoking/tobacco equivalent/chewing tobacco use of more than 10 units per day; 12. Patients with physical or mental disorders rendering them incapable of giving consent; 13. Patients with allergic constitutions (e.g., allergy to polylactic acid, metals, etc.); 14. Patients who are pregnant, breastfeeding, or planning pregnancy within the next year; 15. Patients currently participating in other drug or medical device clinical trials; 16. Patients deemed unsuitable for participation in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The bone growth effect of the horizontal buccal bone plate below the implant abutment along the long axis of the implant site (buccal new bone plate thickness/baseline buccal graft thickness * 100%); | — |
Secondary
| Measure | Time frame |
|---|---|
| postoperative wound healing conditions;Osteointegration;Stability of implant;the time of GBR;surgeon's satisfaction evaluation regarding the malleability, accuracy, and ease of handling of the bone substitute material; | — |
Countries
China
Contacts
Public ContactDong Yan
School of Stomatology, The Fourth Military Medical University
Outcome results
None listed