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Multi-center clinical trial for the safety and effectiveness of oral repair patch for the repair of soft tissue defects in the oral cavity

Multi-center clinical trial for the safety and effectiveness of oral repair patch for the repair of soft tissue defects in the oral cavity

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026398
Enrollment
Unknown
Registered
2019-10-08
Start date
2016-12-12
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

Oral soft tissue defect

Interventions

experimental group: Implantation of oral protective film produced by Beijing Bohuizhen Biotechnology Co., Ltd.
control group:Implantation of oral repair film produced by Yantai Haiao

Sponsors

Wuhan University Stomatological Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 75 years old and be able to act autonomously; (2) To select a 1.5 to 20 cm2 area be an observation wound area; (3) patients with oral soft tissue defects caused by various causes need tissue transplantation to cover the wound; (4) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) With systemic and local contraindications; (2) Patients who are not tolerant of the procedure; (3) Pregnant or breast-feeding women; (4) an allergic constitution group, in particular to a pig source material; (5) The fasting blood glucose was 8.8 mmol/ L or 2 hours after the meal, the blood glucose was 11.1 mmol/ L. (6) The liver and renal function were abnormal (TB, ALT, AST, ALP was 1.5 times higher than the upper limit and Cr was above normal); (7) Patients who received radiotherapy within 4 weeks before screening; (8) With an acute infection in the defect area; (9) Other clinical trials have been attended within 3 months; (10) Other cases considered unsuitable for inclusion by the investigator.

Design outcomes

Primary

MeasureTime frame
12 ±2 days after operation, the success rate of wound repair was removed.;

Countries

China

Contacts

Public ContactWang Xiaona

Beijing Biosis Healing Biological Technology Co., Ltd

wangxiaona@biosishealing.com+86 13552536808

Outcome results

None listed

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