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Efficacy and safety evaluation of the same decalcified bone matrix in combination with silicone prosthesis for rhinoplasty: a prospective, multicenter, randomized, parallel, positive-controlled, third-party blind clinical trial

Efficacy and safety evaluation of the same decalcified bone matrix in combination with silicone prosthesis for rhinoplasty: a prospective, multicenter, randomized, parallel, positive-controlled, third-party blind clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100047243
Enrollment
Unknown
Registered
2021-06-11
Start date
2021-06-11
Completion date
Unknown
Last updated
2022-02-01

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

Conditions

3/5000 rhinoplasty

Interventions

Experimental group:The same decalcified bone matrix combined with silicone prosthesis for rhinoplasty
Control Group:Autogenous cartilage transplantation

Sponsors

Jiangsu Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Subjectively requiring rhinoplasty; 2. Aged 18 to 40 years, gender is not limited; 3. Subjects agree to participate in the clinical trial and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. People with a history of rhinoplasty; 2. Nasal deformity or defect caused by congenital or acquired injury; 3. Rich sebaceous glands in the nose or obvious skin inflammation in the nose; 4. Complicated with serious nasal diseases, such as allergic rhinitis, severe chronic atrophic rhinitis, hypertrophic turbinate, etc.; Nasal functional diseases, such as smelly nose disease, phantom smell and other abnormal smell; 5. CT images indicate deformity of the nose or difficult bone removal of chest ribs; 6. Uncontrolled facial or systemic infection; 7. Pregnant and lactating women; 8. People with allergies and scarring with two or more drug/food allergies; 9. Subjects with fasting blood glucose (venous) greater than 7.0mmol/L; 10. Patients with coagulation dysfunction; 11. People who are taking hormone drugs or taking hormone drugs for a long time; 12. Patients with autoimmune diseases, malignant tumors, tuberculosis and other serious basic diseases; 13. Patients with serious cardiovascular and cerebrovascular diseases; 14. People with mental illness or mental disorder; 15. abnormal liver and kidney function (ALT, AST, Cr, BUN any above the upper limit of the normal value); 16. Subjects who participated in or plan to participate in clinical studies of other drugs or medical devices within 3 months before the screening visit; 17. Other conditions deemed unsuitable for inclusion by the researcher.

Design outcomes

Primary

MeasureTime frame
satisfaction;

Countries

China

Contacts

Public ContactHuang Jinlong
1870714305@qq.com+86 13809041735

Outcome results

None listed

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