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临床试验/NCT06371027
NCT06371027已完成不适用

Novel Silk Fibroin Nanofiber Membrane Using Minimally Invasive Surgery in Treatment of Periodontal Intrabony Defects: A Randomized Clinical Trial

October 6 University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects

研究概览

简要总结

Clinically and radiographically by cone beam CT evaluate the regenerative potentials of silk fibroin (SF) nanofiber membrane, using minimally invasive surgery, for the regenerative treatment of intrabony periodontal defects.

详细描述

Periodontitis is a bacterially induced chronic inflammation of the periodontium that extends beyond the gingiva and involves progressive and irreversible destruction of the connective tissue attachment of the teeth.The treatment involves debridement of the tooth surface and the adjacent areas employing scaling, root planing and periodontal flap surgery. While scaling and root planing are non-surgical treatment modalities and are conservative; periodontal flap surgery gains access to the underlying bone for complete debridement achieving pocket depth reduction, periodontal regeneration, and maintenance of periodontium in healthy condition feasible by routine home care methods by the patient.

Guided tissue regeneration (GTR) therapy is playing a key role in the management of intrabony defects. Current resorbable and non-resorbable membranes act as a physical barrier to avoid connective and epithelial tissue down-growth into the defect, favoring the regeneration of periodontal tissues. However, these conventional membranes possess many structural, mechanical, and bio-functional limitations and the "ideal" membrane for use in periodontal regenerative therapy has yet to be developed. Based on a graded-biomaterials approach, we have hypothesized that a biologically active and spatially designed and functionally graded nanofibrous material that mimics closely the native extracellular matrix ECM could succeed as the next generation of GTR membranes for periodontal tissue engineering. In the current study, using a minimally invasive surgical approach, we will compare a novel silk fibroin (SF) nanofiber membrane to collagen membrane as a regenerative treatment of intrabony periodontal defects.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age above 18 years old.
  • Patients with periodontitis Stage III Grade C.
  • Single-rooted and multi-rooted vital teeth in either the maxilla or the mandible.
  • Probing depth (PD) ≥5 mm at the site of intraosseous defects 4 weeks following initial therapy.
  • Periodontal 2- or 3-wall intrabony defects (IBDs), measuring ≥3 mm from the alveolar crest to the defect base, estimated by radiographic evaluation (Periapical X-ray).
  • Absence of a history of periodontal surgery at the involved sites in the last 6 months.
  • History of compliance with oral hygiene instructions and periodontal recall.
  • Full mouth plaque score and bleeding on probing score ≤20% after phase I therapy.

排除标准

  • Patients with systemic illness known to affect the outcome of periodontal therapy, including diabetes, immune deficiencies, etc.24
  • Pregnant and lactating women
  • Current use of any form of tobacco.

结局指标

主要结局

Novel Silk Fibroin Nanofiber Membrane using minimally invasive surgery in Treatment of Periodontal Intrabony Defects

时间窗: 6 months after surgery

The primary outcome variable in this clinical study will be the change in bone fill as measured by cone beam CT

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohamed Hamdy Hamed El-Shesheny

principle investigator. mohamed hamdy

October 6 University

研究点 (1)

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