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A prospective, multicenter, single blind, randomized controlled clinical trial on the efficacy and safety of guided tissue regeneration membrane (gelatin polycaprolactone composite membrane) for the repair of oral soft tissue defects

A prospective, multicenter, single blind, randomized controlled clinical trial on the efficacy and safety of guided tissue regeneration membrane (gelatin polycaprolactone composite membrane) for the repair of oral soft tissue defects

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086999
Enrollment
Unknown
Registered
2024-07-17
Start date
2021-07-30
Completion date
Unknown
Last updated
2024-12-02

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

Conditions

Repair of oral and maxillofacial soft tissue defects

Interventions

Experimental group:Repair of oral soft tissue wounds using guided tissue regeneration membrane produced by Nuomodulus (Suzhou) Medical Technology Co., Ltd
Control group:Repair surgical wounds using the oral restoration membrane produced by Yantai Zhenghai Biotechnology Co., Ltd

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18-70 years old, gender unlimited 2. Oral soft tissue defects caused by various reasons that require tissue graft coverage on the wound surface; 3. The intended size of the wound to be observed is 1.5cm ² -2cm ²; 4. Participants voluntarily participate in this clinical trial and sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. diabetes (fasting blood glucose = 8.8 mmol/L or blood glucose = 11.1 mmol/L 2 hours after meal); 2. Patients with acute infections in the defect area or throughout the body; 3. Patients who cannot tolerate surgery; 4. Patients with liver and kidney dysfunction (AST, ALT, creatinine>2 times normal), and those with abnormal coagulation mechanisms (PT, APTT>2 times normal); 5. Pregnant or lactating women; 6. Patients with a history of radiotherapy or chemotherapy within six months before surgery; 7. Individuals with autoimmune diseases; 8. Those who cannot accept bovine derived materials; 9. Patients with contraindications for surgery; 10. Alcoholics and drug addicts; 11. Patients with hypoalbuminemia (serum albumin<30g/L) and cachexia; 12. Those who have participated in other clinical trials within one month before surgery; 13. The researchers believe that it is not suitable for the participants to be included.

Design outcomes

Primary

MeasureTime frame
Grade A healing rate of repair area wounds one month after surgery;—

Secondary

MeasureTime frame
performance evaluation of devices;Grade A wound healing rate 10 days and 3 months after surgery;Wound healing time;Satisfaction assessment of surgical area;Evaluation of wound contracture;—

Countries

China

Contacts

Public ContactGuo Chuanbin

Peking University School and Hospital of Stomatology

guodazuo@sina.com+86 10 8219 5382

Outcome results

None listed

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