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Assessing the safety and effectiveness of dental implant systems for dental implant restorations: a prospective, multicenter, single-group target study

Assessing the safety and effectiveness of dental implant systems for dental implant restorations: a prospective, multicenter, single-group target study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000030426
Enrollment
Unknown
Registered
2020-03-01
Start date
2020-02-28
Completion date
Unknown
Last updated
2020-03-02

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

Conditions

Patients diagnosed before surgery with missing or defective dentition and needing implant restoration

Interventions

Intervention group:Implant implantation

Sponsors

West China Stomatological Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
Male
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Patients with missing or defective dentition and needing implant restoration; 2. The implantation area has no soft or hard tissue defects or lesions that affect the implantation; 3. Subjects are 18 to 70 years old (including 18 and 70 years old), and the gender is not limited; 4. Subjects fully understand the benefits and risks of this trial, are still willing to participate, and sign an informed consent.

Exclusion criteria

Exclusion criteria: 1. Those with uncontrolled endocrine and metabolic diseases, such as patients with abnormal blood glucose (fasting blood glucose is still greater than 8mmol / L after control); 2. Patients with hematological diseases, such as patients with leukemia; 3. Those with uncontrolled cardiovascular disease, such as patients with stage III and IV hypertension, angina pectoris, etc .; 4. System or local osteopathy that are contraindicated in implant repair, such as bone tuberculosis, osteitis, softening disease, bone tumor, severe osteoporosis, and pathological changes of the jaw; 5. People with systemic immune diseases; 6. Those who are allergic to titanium; 7. Severe smokers (more than 10 cigarettes per day); 8. With long-term use of special drugs such as steroid hormones, anticoagulants, bisphosphonates, etc.; 9. Pregnant or lactating women, or women with a birth plan within the next two years; 10. Nervous system diseases, such as patients with epilepsy; 11. Pathological oral mucosal lesions; 12. Patients with previous history of Shegren's syndrome; 13. Patients after head and neck radiotherapy; 14. Those who are mentally incapacitated or unable to understand the requirements of participating in the research, such as being unable to express, read and understand the subjective questionnaires of the subjects specified in the research plan; 15. With uncontrolled periodontal disease or poor oral hygiene; 16. With any of the following conditions: bad occlusal relationship, nocturnal molars, limited mouth opening, too small gaps between missing teeth, and too short occlusion distance; 17. Patients who participated in other clinical trials within three months; 18. Other circumstances that the researcher considers unsuitable for testing.

Design outcomes

Primary

MeasureTime frame
1-year success rate of implant placement after repair;

Countries

China

Contacts

Public ContactQianbing Wan

West China Stomatological Hospital of Sichuan University

champion@scu.edu.cn+86 13688339355

Outcome results

None listed

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