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

Study Overview
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Brief Summary
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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
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Peking University School of Stomatology

Conditions
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Guided Tissue Regeneration, Extracellular Matrix Scaffold of Small Intestinal Submucosa

Intervention / Treatment
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* Procedure: Flap surgery+bone graft+guided tissue regeneration


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: periodontitis patients with stage III to IV, grade C had one or more intrabony defects with a depth of ≥3 mm; PD≥5mm after initial periodontal therapy. Exclusion Criteria: smokers, pregnant female, other systematic disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Small Intestinal Submucosa Membrane<br> | Procedure: Flap surgery+bone graft+guided tissue regeneration<br>* after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.<br>|
| Active Comparator: Bio-guide<br> | Procedure: Flap surgery+bone graft+guided tissue regeneration<br>* after flap elevation and debridement, intrabony defect was filled with Bio-Oss and covered with membrane.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical attachment loss | before and 6 months after surgery, examine the changes of CAL | Baseline and 6 months after surgery | 
| clinical attachment loss | before and 12 months after surgery, examine the changes of CAL | baseline and 12 months after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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guided tissue regeneration, Small Intestinal Submucosa, Randomized Controlled Clinical Trial