Maxillary edentulism and bone defect
Conditions
Interventions
Experimental group:AI-assisted mixed reality integrated navigation surgery
Control group:Conventional navigation surgery
Sponsors
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Male or female patients aged 18 to 70 (inclusive of 18 and 70); 2. Patients with severe alveolar ridge atrophy in the maxilla, requiring zygomatic implant restoration; 3. Patients with jawbone defects, requiring zygomatic implant restoration; 4. Normal mouth opening degree (>= 40 mm); 5. Before any experimental steps related to the study are carried out, the subjects voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Oral mucosal lesions (such as lichen planus); 2. Presence of space-occupying lesions in the oral cavity (including cysts, tumors, etc.); 3. Systemic diseases that affect bone healing, wound healing and dental implant treatment (such as uncontrolled stable diabetes, fasting blood glucose still >= 8.8 mmol after drug control); 4. Uncontrolled stable severe hypertension; 5. Contraindications for conventional implant surgery and oral surgeries, including bone grafting surgeries; 6. Heart diseases (grade II or above cardiac function disorders); 7. Patients with abnormal liver or kidney function; 8. Obese patients with a body mass index (BMI) > 28 kg/m^2; 9. Patients who have received full-dose radiotherapy, local radiotherapy to the head or neck; 10. Patients requiring long-term high-dose steroid treatment; 11. Patients who have received treatment with drugs that may affect or promote bone metabolism (such as bisphosphonates) within the past 3 months or are currently receiving such treatment; 12. Patients who have been using antibiotics continuously or undergoing chronic anti-inflammatory treatment (>= 3 times per week) within 4 weeks before the surgery; 13. Heavy drinking or long-term drug abuse; 14. Patients with immunodeficiency; 15. Smoking tobacco equivalents or chewing tobacco more than 10 times per day; 16. Patients with physical or mental impairments that affect oral hygiene care; 17. Patients allergic to the product; 18. Pregnant or lactating women; 19. Patients considered not to be compliant and unable to participate in the trial by the investigator; 20. Patients who participated in other drug or device clinical trials within 30 days before the surgery (on the 0th day of the study); 21. Patients whose zygomatic bone height, width and thickness are insufficient to accommodate zygomatic implants.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant exit deviation;Implant entry deviation;Angle deviation of the implant; | — |
Secondary
| Measure | Time frame |
|---|---|
| AI correction rate;Operation time;Doctor's evaluation;Intraoperative complications; | — |
Countries
China
Contacts
Public ContactYiqun Wu
Shanghai Ninth People's Hospital, Shanghai Jiao Tong University School of Medicine
Outcome results
None listed