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A prospective single-group objective-value clinical study evaluating the accuracy of an oral implant surgical robot

A prospective single-group objective-value clinical study evaluating the accuracy of an oral implant surgical robot

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050885
Enrollment
Unknown
Registered
2021-09-07
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-05-09

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

Conditions

Oral planting

Interventions

Experimental group:Guided and completed by the trial product

Sponsors

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients aged 18-70 years, regardless of gender; 2. Patients with dentition defect or absence and natural adjacent teeth; 3. Patients with sufficient bone mass at the defect site; 4. Patients without crown restoration history; 5. Mouth opening is normal (>= 40 mm); 6. Patients who have received implant repair with oral implant surgical robot system and have consented to the treatment and voluntarily signed the informed consent.

Exclusion criteria

Exclusion criteria: 1. Insufficient height and width of alveolar bone; 2. Patients treated by secondary implantation; 3. Patients with systemic or local contraindications to implant repair; 4. patients with severe periodontitis and diabetes; 5. Patients with keratinized gingival loss and insufficient soft tissue coverage in the operative area; 6. Patients with uncontrolled primary diseases of heart, lung, brain, kidney and other important organs; 7. Patients with acute infectious diseases, mental diseases and systemic diseases; 8. Pregnant and intended pregnant women of childbearing age and lactating women; 9. Neurological diseases, such as epilepsy; 10. Mental patients or persons with mental disorders; 11. Pathological changes of mucosa; 12. Head and neck radiotherapy patients; 13. Maxillary dysplasia or pathological changes; 14. Long-term use of special drugs such as hormones, anticoagulants, bisphosphonates, etc.; 15. Smokers who smoke more than 10 cigarettes per day; 16. Patients in critical condition who are difficult to accurately evaluate the effectiveness and safety of the test; 17. Those who have participated in other medical device tests within 3 months; 18. The researcher considers it inappropriate to participate in the experiment.

Design outcomes

Primary

MeasureTime frame
Angle deviation;

Countries

China

Contacts

Public ContactLai Hongchang

Shanghai Ninth People's Hospital, Shanghai Jiaotong University School of Medicine

Hongchanglai@126.com+86 13501881537

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 9, 2026