Actively Recruiting
The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial
Led by Peking University · Updated on 2024-05-10
20
Participants Needed
1
Research Sites
92 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
The Efficacy of Guided Tissue Regeneration With Extracellular Matrix Scaffold of Small Intestinal Submucosa (SIS) Membrane: a Randomized Controlled Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 65 years
- Diagnosed with periodontitis stage III to IV, grade C
- Have one or more intrabony defects with a depth of 3 mm or more
- Pocket depth of 5 mm or greater after initial periodontal therapy
You will not qualify if you...
- Current smokers
- Pregnant females
- Presence of other systemic diseases
AI-Screening
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Trial Site Locations
Total: 1 location
1
Peking University Hospital of stomatology
Beijing, Beijing Municipality, China
Actively Recruiting
Research Team
X
Xiaowei Jia
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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