NCT07611630尚未招募不适用
Construction of a Long-Acting Sustained-Release Minocycline Hydrochloride Delivery System Based on Hyaluronic Acid-Nanoclay Composite Hydrogel and Its Application in the Treatment of 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 study aims to construct and systematically evaluate a multifunctional synergistic drug delivery system based on a hyaluronic acid-nanoclay composite hydrogel to achieve integrated treatment of periodontitis encompassing "infection control, inflammation regulation, and bone regeneration promotion." Through material design, in vitro functional validation, and in vivo efficacy evaluation, the study will elucidate the intrinsic relationships and synergistic mechanisms among "material structure, controlled drug release, and biological effects" within this system, thereby providing a theoretical basis and experimental foundation for the development of smart periodontal regenerative materials with clinical translational potential.
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.
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.
- •Drug Allergy: Known allergy to minocycline (MH), hyaluronic acid (HA), or similar chemical components.
研究者
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