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RECRUITING
NCT05789914
NA

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

Sponsor: Peking University

View on ClinicalTrials.gov

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.

Official title: Peking University School of Stomatology

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2023-03-28

Completion Date

2025-01-01

Last Updated

2024-05-10

Healthy Volunteers

No

Interventions

PROCEDURE

Flap surgery+bone graft+guided tissue regeneration

after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.

Locations (1)

Peking University Hospital of stomatology

Beijing, Beijing Municipality, China