Skip to content

Clinical evaluation of self-developed oral implant dynamic navigation system

Clinical evaluation of self-developed oral implant dynamic navigation system

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035516
Enrollment
Unknown
Registered
2020-08-13
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dentition defect

Interventions

Group B:Brainlab navigator
Group A:Domestic autonomous navigator

Sponsors

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1) Male or female patients aged 18 to 70 years; 2) Maxillary edentulous or maxillary terminal dentition; 3) The maxillary hard tissue defect conforms to Cawood & Howell classification IV-VI; 4) Normal mouth opening (>=40 mm); 5) Cheekbone width >=12mm; 6) Before implementing any research-related experimental procedures, the experimenter's resources sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. There is local inflammation in adjacent teeth, including uncontrolled periodontitis (periodontal probing depth> 4mm); 2. There are untreated acute and chronic apical periodontitis in adjacent teeth; 3. Oral mucosal lesions (such as lichen planus); 4. There are space-occupying lesions in adjacent teeth (including cysts, tumors, etc.); 5. System diseases that affect bone healing, wound healing and dental implant treatment (such as uncontrolled diabetes, fasting blood glucose is still >=8.8mmol/L under drug control); 6. Uncontrolled and stable severe hypertension; 7. Contraindications of conventional implant surgery and oral surgery; 8. Heart disease (heart function disease of grade II and above); 9. Patients with insufficiency or abnormal liver and kidney function; 10. Obese patients, body mass index BMI> 28 kg/m2; 11. Received full-dose radiotherapy, a history of local radiotherapy on the head or neck; 12. Patients who need long-term high-dose steroid therapy; 13. Patients who have been treated with drugs (such as bisphosphonates) that may affect or promote bone metabolism within the past 3 months; 14. In the first 4 weeks of starting the operation, continuous antibiotic treatment or chronic anti-inflammatory treatment (>=3 times a week); 15. Alcoholism or long-term drug abuse; 16. Patients with immune insufficiency; 17. Smoking/tobacco equivalent/chewing tobacco more than 10 pieces per day; 18. Physical or mental defects affect oral hygiene care; 19. Female patients who are pregnant or breastfeeding; 20. Patients who the researcher believes that they have poor compliance and cannot participate in the trial; 21. In the first 30 days of starting the operation (study day 0), the patient participated in the clinical trial of other drugs or devices.

Design outcomes

Primary

MeasureTime frame
Implant placement accuracy;

Secondary

MeasureTime frame
operation time;Patient satisfaction with surgery;Postoperative complications;Implant retention;

Countries

China

Contacts

Public ContactFeng Wang

The Ninth People's Hospital Affiliated to Shanghai Jiaotong University School of Medicine

diana_wangfeng@aliyun.com+86 13651998106

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026