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Randomized, single-blind, parallel controlled, multicenter clinical study to evaluate the efficacy and safety of SIS in alveolar bone and soft tissue reconstruction

Randomized, single-blind, parallel controlled, multicenter clinical study to evaluate the efficacy and safety of SIS in alveolar bone and soft tissue reconstruction

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021966
Enrollment
Unknown
Registered
2019-03-18
Start date
2018-07-01
Completion date
Unknown
Last updated
2019-03-25

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

Conditions

alveolar bone defect

Interventions

Sponsors

The Third Affiliated Hospital of the Chinese People's Liberation Army Air Force Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Aged 18 to 65 years,male or female. ? Bone graft is needed after a single tooth extraction. ? Bone defect =5mm. ? No surgical contraindications. ? Subjects are willing to participate in the trial and sign the informed consent document. ? If it is a apical cyst, it needs to be treated by tooth extraction, and the cyst diameter is =1cm.

Exclusion criteria

Exclusion criteria: 1. Involvement of another clinical trial within 3 months. 2. Bone defect arising from invasive, malignant bone tumors. 3. Receiving medications which may affect or promote bone metabolism within 3 months. 4. Bone defect arising from acute infectious disease or metabolic bone disease. 5. Abnormal function of cardiac or liver or kidney,( NYHA II or above\ ALTAST 2 times higher than normal or abnormal creatinine). 6. Poor control of diabetes (FPG=8.0mmol/L). 7. Mental disorder without autonomous ability. 8. Patients allergic to collagen. 9. Pregnancy or lactation. 10. Other condition causing false images. 11. The doctor judges other circumstances in which he cannot participate in the trial.

Design outcomes

Primary

MeasureTime frame
Imageology diversity;

Secondary

MeasureTime frame
Whether membrane the damaged;Clinical surgical incision healing evaluation;Rejection reaction;Symptoms after implant;

Countries

China

Contacts

Public ContactKaijin Hu
hukaijin@fmmu.edu.cn+86 13991106298

Outcome results

None listed

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