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A multicenter, randomized, single-blind, controlled trial for evaluating the safety and efficacy of the absorabable silk fibroin membrance

A multicenter, randomized, single-blind, controlled trial for evaluating the safety and efficacy of the absorabable silk fibroin membrance

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016759
Enrollment
Unknown
Registered
2018-06-22
Start date
2017-06-01
Completion date
Unknown
Last updated
2018-06-25

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

Conditions

used for alveolar ridge preservation after tooth extraction.

Interventions

Test:used absorabable silk fibroin membrance
Control:used Bio-gide membrance

Sponsors

Hospital of Stomatology of Wuhan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. The subjects age was from 18 to 65 and the sex was not limited; 2. The vital signs were normal; 3. Subjects were to extract mandibular posterior teeth for various therapeutic purposes; 4. Subjects were conscious; 5. Subjects participated in the clinic trial voluntarily, and the informed consents were signed by the subjects or their legal representative.

Exclusion criteria

Exclusion criteria: 1. Hypertension: after treatment, systolic pressure was more than 140 mmHg and diastolic pressure was more than 90 mmHg; 2. Subjects had a history of angina or myocardial infarction; 3. Subjects had diabetes mellitus (After treatment, the blood glucose value two hours after meal was more than 11.1mmol/L); 4. Patients had malignancies or received chemordiation; 5. Anemia, hemoglobin is less than 10mg/dL, obvious active hemorrhage; 6. The test values of liver and kidney function were morn than1.5 times the upper limit of normal; 7. Female subject was pregnant or breastfeeding; 8. Bisphosphonates medicines were orally taken in the long term for osteoporosis; 9. Subjects were unwilling to sign informed consent for various reasons; 10. In any case, subjects were not suitable for the treatment judged by the researchers.

Design outcomes

Primary

MeasureTime frame
the height, width change value of alveolar ridge;

Countries

China

Contacts

Public ContactWang Xiao

Peking University Third Hospital

bysywangxiao@163.com+86 15611908360

Outcome results

None listed

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