NCT05789914

The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial

Peking University School of Stomatology

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The most commonly used barrier membrane material in guided tissue regeneration is absorbable collagen membrane. Although the collagen membrane has a good barrier effect, it lacks the growth factors needed for periodontal tissue regeneration, which affects the effect of collagen membrane on periodontal tissue regeneration. Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane is a novel absorbable membrane that retains the extracellular matrix structure and is conducive to vascular ingrowth and tissue repair. The in vitro study showed that SIS membrane had excellent biocompatibility and certain antibacterial effect. Preclinical study also showed that SIS membrane significantly promoted the differentiation of bone marrow mesenchymal stem cells into osteoblasts, and promoted bone regeneration more effectively than collagen mechanism materials. SIS membrane can be used in soft tissue wound repair, guided bone regeneration, site preservation and other surgeries, and has achieved good therapeutic effects. However, whether the application of SIS membrane can achieve good therapeutic effect on periodontal guide tissue regeneration is still unclear. Therefore, in this study, the effects of guide tissue regeneration with collagen membrane and SIS membrane were compared through a randomized controlled clinical study.

Conditions

• Guided Tissue Regeneration
• Extracellular Matrix Scaffold of Small Intestinal Submucosa

Interventions

Type	Name	Description
PROCEDURE	Flap surgery+bone graft+guided tissue regeneration	after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-06-01
• Completion: 2025-01-01
• First posted: 2023-03-29
• Last updated: 2024-05-10

Locations

1 site across 1 country: China