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A randomized controlled clinical trial for the safety and effectiveness of the dental implant robotic surgery system

A randomized controlled clinical trial for the safety and effectiveness of the dental implant robotic surgery system

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035334
Enrollment
Unknown
Registered
2020-08-08
Start date
2020-08-10
Completion date
Unknown
Last updated
2020-08-10

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

Conditions

Dentition defect

Interventions

Group DIRS:Implant placement by the dental implant robotic surgery system
Group HAND:Implant placement by skilled dentists freehand

Sponsors

School of Stomatology, the Fourth Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years, no limitation on gender. 2. Patients with dentition loss or defect who required restoration with dental implants. 3. The implant site has no defect or lesion which would affect implant placement. 4. Subjects voluntarily participate and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. Poor general and nutritional status (e.g. ALT/AST 4 times higher than normal). 2. Uncontrolled endocrine diseases (e.g. fasting blood glucose >= 10mmol/L). 3. Uncontrolled hematological diseases or cardiovascular diseases. 4. Systemic or local bone diseases which were considered as contraindications for implant placement, such as bone tuberculosis, osteitis and bone tumor. 5. Systemic immune diseases or infectious diseases. 6. Long-term use of special drugs such as hormone, anticoagulant and bisphosphonates. 7. Women who are pregnant or intend to be pregnant or lactating women. 8. Neurological diseases, such as epilepsy. 9. Mental illness or mental disorders. 10. Pathological changes of jaw bone. 11. Pathological mucosal lesions. 12. Patients who received radiotherapy of the head and neck. 13. Sjogren's syndrome. 14. Uncontrolled periodontal diseases or poor oral hygiene. 15. Bad occlusal habits, such as bruxism. 16. Smoking more than 10 cigarettes per day. 17. Those who had participated in other clinical trials in recent three months. 18. Other conditions which were considered unsuitable for the trial by the researchers.

Design outcomes

Primary

MeasureTime frame
The accuracy of implant placement;

Secondary

MeasureTime frame
The degree of satisfaction on the software function and machine operation;

Countries

China

Contacts

Public ContactBai Shizhu

School of Stomatology, the Fourth Military Medical University

baishizhu@foxmail.com+86 029-84776511

Outcome results

None listed

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