NCT07611617尚未招募不适用
Study on Injectable Hydrogel Loaded With BMP-2 for Promoting Alveolar Bone Regeneration Induced by Periodontitis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
研究概览
简要总结
This project aims to construct an injectable self-healing hydrogel loaded with BMP-2, with optimized gelation time and mechanical strength to meet the requirements for periodontal pocket filling, for the treatment of periodontitis and acceleration of tissue repair, achieving a "bactericidal-anti-inflammatory-regenerative" trinity function. This project will provide a novel intelligent material for promoting alveolar bone regeneration in periodontitis and establish a theoretical paradigm for the precise intervention of oral infectious diseases.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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.
研究者
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