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

NCT05789914 | Recruiting

• 1 other identifier: PKUSSIRB-202384005
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

guided tissue regeneration; Small Intestinal Submucosa; Randomized Controlled Clinical Trial

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

Small Intestinal Submucosa Membrane

EXPERIMENTAL

Procedure: Flap surgery+bone graft+guided tissue regeneration

Bio-guide

ACTIVE COMPARATOR

Procedure: Flap surgery+bone graft+guided tissue regeneration

Interventions

Flap surgery+bone graft+guided tissue regeneration PROCEDURE

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

Bio-guide; Small Intestinal Submucosa Membrane

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• smokers, pregnant female, other systematic disease

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University Hospital of stomatology

Beijing, Beijing Municipality, China

RECRUITING

Central Study Contacts

Xiaowei Jia

CONTACT

+8601082195759; keyanchuethics@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 29, 2023
• Study Start: March 28, 2023
• Primary Completion: June 1, 2024
• Study Completion: January 1, 2025
• Last Updated: May 10, 2024

Record last verified: 2024-05

Locations

CN (1)