Study on Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration
Clinical Study of Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Promoting Alveolar Bone Regeneration
Based on the mechanism of intramembranous ossification of the alveolar bone, it is necessary to design a biomimetic membrane material based on the principle of GBR (Guided Bone Regeneration) to simulate the biological microenvironment of alveolar bone regeneration, promote the direct differentiation of stem cells into osteoblasts and rapid mineralization, thereby achieving the goal of alveolar bone regeneration.
This section, based on bionic principles, proposes to enhance the mechanical properties of the collagen membrane with silk fibroin to achieve synergistic regeneration of periodontal bone/soft tissue.
This project employs silk fibroin-reinforced collagen membrane technology to overcome the dual bottlenecks of insufficient strength and excessively rapid degradation of existing materials; establishes a "structure-guided, mechanically supported, factor-controlled release" trinity regeneration strategy to achieve precise repair of periodontal composite tissues.
This study will provide new materials and methods for periodontal regeneration and offer a theoretical reference for the combined regeneration of other hard/soft tissues.
研究概览
研究类型
介入性
注册 (估计的)
80
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习联系方式
- 姓名:Wenjie Ren
- 电话号码:8613937354075
- 邮箱:13937354075@163.com
参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Clinical Diagnosis: Meets the 2018 International Classification of Periodontal Diseases, diagnosed with Stage III or IV periodontitis.
- Bone Defect Characteristics: At least one affected tooth presents with a deep periodontal pocket (PPD ≥5 mm), and CBCT imaging confirms the presence of significant vertical bone resorption or angular bone defects (these defect types are most suitable for in-situ hydrogel filling and guided regeneration).
- Age and General Condition: Aged between 18 and 70 years, any gender, generally in good systemic health.
- Compliance and Consent: The subject is able to understand the study procedures, voluntarily sign the informed consent form, and commit to returning for follow-up visits as required (1, 3, 6, 12 months).
Exclusion Criteria:
- Systemic Interference with Bone Metabolism: Presence of poorly controlled diabetes (HbA1c > 7%), osteoporosis, or long-term use of medications affecting bone metabolism such as bisphosphonates or glucocorticoids within the past six months.
- Local Anatomical Limitations: The affected tooth has a vertical root fracture, severe periapical pathology, or a residual root that is deemed non-restorable and without preservation value.
- Factors Interfering with Healing: Heavy smokers (average > 10 cigarettes per day), as impaired microcirculation can significantly compromise the biological effects of the hydrogel.
- Special Physiological Periods: Pregnant or breastfeeding women. Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他:No treatment
|
Silk Fibroin-Reinforced Collagen-Based Composite Membrane for Periodontal Bone Tissue Regeneration
|
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Vertical Bone Defect Fill Height (VBH)
大体时间:Up to 12 month
|
Three-dimensional reconstruction using CBCT (Cone Beam Computed Tomography) to measure the change in distance from the base of the bone defect to the alveolar crest between pre-operative and post-operative scans.
|
Up to 12 month
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Alveolar Bone Density
大体时间:Up to 12 month
|
Gray value calculation of the region of interest (ROI) using CBCT software.
|
Up to 12 month
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员:Wenjie Ren、The First Affiliated Hospital of Xinxiang Medical College
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月1日
初级完成 (估计的)
2027年12月31日
研究完成 (估计的)
2028年12月31日
研究注册日期
首次提交
2026年4月9日
首先提交符合 QC 标准的
2026年5月3日
首次发布 (实际的)
2026年5月8日
研究记录更新
最后更新发布 (实际的)
2026年5月8日
上次提交的符合 QC 标准的更新
2026年5月3日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.