Evaluating role of placental extract in extraction socket healing using chitosan microspheres as delivery vehicle
试验速览
- 阶段
- 1/2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluation of pain, swelling, mucosal healing, and bone regeneration following placement of chitosan–placental extract microspheres in extraction sockets compared to control.
研究概览
简要总结
Introduction:
Following tooth extraction, the socket undergoes a series of remodeling and regenerative processes to restore the normal continuity of the bone. However, in certain cases, this complex regenerative process may be delayed or incomplete. The placenta serves as a natural reservoir of biologically active compounds—including hormones, proteins, peptides, growth factors, nucleic acids, glycosaminoglycans (GAGs), and polydeoxyribonucleotides (PDRNs)—all of which are essential for fetal growth and development. Owing to this rich composition, placental extracts have demonstrated notable healing potential and have been widely used over the years for various conditions such as ulcers, burn injuries, chronic wounds, pressure ulcers, and as post-surgical dressings. Chitosan, a naturally occurring polysaccharide derived from insect exoskeletons, crustacean shells, and fungal cell walls, is also known as soluble chitin. It is non-toxic, biocompatible, biodegradable, and its degradation products are harmless and fully absorbed by living organisms. These properties make chitosan an excellent carrier medium for drug delivery systems. In our study, we utilized the unique properties of chitosan to incorporate placental extract, creating a stable formulation aimed at enhancing wound healing. To further evaluate this product, we assessed its drug release profile, particle size distribution, cytotoxicity, and performed scanning electron microscopy (SEM) analysis.
Objectives of the project:
- To develop biocompatible chitosan microspheres incorporating human aqueous placental extract (APE) for localized regenerative therapy in dental extraction sockets.
- To achieve sustained and controlled release of placental bioactive molecules, preserving their therapeutic activity over time.
- To enhance tissue healing and regeneration in dental extraction sites through a synergistic combination of chitosan and placental extract.
- To design a microsphere system free of cytotoxic crosslinkers, ensuring safe local application in the oral cavity.
To provide a tailored, clinically translatable delivery platform that overcomes limitations of current synthetic and natural polymer systems for improved bone and soft tissue healing in extraction sockets.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 13.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •It will be conducted on 10 patients undergoing bilateral mandibular third molar/premolar removal at the Department of Oral and Maxillofacial Surgery, Meenakshi Ammal Dental College and Hospital.
- •Only medically fit patients classified as ASA I or II, and consenting to participate will be included.
排除标准
- •Patients with habits such as smoking or alcohol use, systemic illnesses contraindicating extraction, pregnancy (first and third trimester), bleeding disorders, malignancies, those on oral contraceptives, or patients showing allergic response to placentrex on prick testing will be excluded.
结局指标
主要结局
Evaluation of pain, swelling, mucosal healing, and bone regeneration following placement of chitosan–placental extract microspheres in extraction sockets compared to control.
时间窗: Baseline (Day 0), Day 1, Day 3, Day 7, Day 14, 1 month, and 3 months post-extraction.
次要结局
未报告次要终点
研究者
Iniya Shree
Meenakshi Ammal Dental College and Hospital