After a single tooth extraction or insufficient bone mass, there is a bone defect. It is proposed to perform guided bone regeneration and simultaneous implant implantation surgery
Conditions
Interventions
Control group:Receiving the bone tissue adhesive from Suzhou Jiuxin Medical Technology Co., Ltd. for guided bone regeneration with simultaneous dental implant placement, with the bone tissue adhesive
Trial group:Receiving guided bone regeneration with simultaneous dental implant placement using a bone tissue adhesive from Suzhou Jiuxin Medical Technology Co., Ltd. mixed with bone graft particles.
Sponsors
Shandong First Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Patients with insufficient bone mass who need immediate implant restoration; 2. At least 2 mm of apical bone below the alveolar socket for implant fixation; 3. Ages 18 to 70, male or female who is not pregnant and not breastfeeding; 4. Voluntary participation in the trial and signing of the informed consent form; 5. No obvious inflammation, infection or lesions in the oral soft tissues; 6. Willing to cooperate with the research protocol and undergo regular postoperative visits.
Exclusion criteria
Exclusion criteria: 1. Those with a pregnancy plan within the next two years; 2. Patients with poor overall condition and nutritional status; 3. Patients with endocrine and metabolic diseases, hematological disorders, or cardiovascular diseases that are not under control; 4. Suffering from systemic or localized bone diseases such as osteomalacia, osteosclerosis, osteo tuberculosis, osteomyelitis, bone tumors, etc; 5. Individuals with systemic immune diseases; 6. Patients with poorly controlled diabetes (fasting blood glucose remains =8.0 mmol/L despite medication); 7. Individuals with titanium allergies; 8. Long-term use of special medications such as hormones and anticoagulants; 9. Pregnant and lactating women; 10. Patients with mental illness, psychological disorders, or neurological conditions such as epilepsy; 11. Individuals with mandibular and mucosal lesions; 12.After head and neck radiotherapy; 13. Patients with Sjögren's syndrome; 14. Those with untreated periodontal disease or extremely poor oral hygiene; 15. Individuals with malocclusion habits such as bruxism; 16. Exclusion of participants who have participated in other clinical trials within the past six months; 17. Researchers consider other circumstances deemed unsuitable for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant stability coefficient (ISQ);Bone resorption volume;Physiological changes;Satisfaction with the repaired effect;Evaluation of the operational performance of equipment;Incidence of adverse events;Incidence of device defects;Health status of soft tissues around implants; | — |
Countries
China
Contacts
Public ContactLiang Jin
Shandong First Medical University
Outcome results
None listed