An intervention of autologous Low Concentration Platelet Rich Plasma at surgically extracted mandibular 3rd molar site with a fractal viewpoint to scrutinize the changes - A pilot study.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- trismus.
研究概览
简要总结
The pilot study titled "An intervention of autologous Low Concentration of Platelet-Rich Plasma impregnated sutures at surgically extracted mandibular 3rd molar site with a Fractal viewpoint to scrutinize the changes" aims to explore the effects of low concentration platelet-rich plasma (L-PRP) infused sutures on healing following the extraction of mandibular third molars.
The objectives of the study include assessing wound epithelization, bone density, mineral content at the extraction site after a healing period of 10-12 weeks, intensity of post-operative pain, degree of trismus, and the inflammatory response on the suture surface. The study is designed as a prospective, randomized control trial with a sample size of 30 participants (10 in each group), focusing on patients aged 25-50 undergoing surgical extraction of mandibular third molars.
Parameters evaluated in the study include:
- Epithelization Status: Analyzing the healing of the wound.
- Bone Density and Mineral Content: Assessing alveolar bone conditions after healing with fractal dimensions.
- Pain Levels: Measurement via a Visual Analogue Scale at various intervals (24 hours and 3 days post-surgery).
- Trismus: Evaluating the extent of restricted jaw opening.
- Inflammatory Cell Count: Examining the suture surface at the surgical site.
The study anticipates providing insightful data on the efficacy of L-PRP in enhancing post-operative recovery in oral surgeries
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I and II planned patients for surgical extraction of impacted mandibular 3rd molars without pathology.
排除标准
- •Pathology associated with mandibular 3rd molar to be extracted.
- •Patients with systemic conditions and diseases like Hypertension, Diabetes Mellitus, AIDS or immunosuppressive diseases, bleeding disorders, bone disorders; pregnant or lactating women; patients allergic to lidocaine, paracetamol or ibuprofen; patients in whom the administration of epinephrine is contraindicated, smokers, alcohol abuse, patients who presented with a jawbone-associated pathology and non-co-operative patients (psychic-motor dysfunction and behaviour disorders), ASA 3, 4 and 5.
结局指标
主要结局
trismus.
时间窗: 24 hours, 3rd day, 7th day, 14th day
A better healing at the surgical site without reduced chances of post-op infection and
时间窗: 24 hours, 3rd day, 7th day, 14th day
Reduction in the perception of post-op pain which is a major factor causing discomfort to the patient.
时间窗: 24 hours, 3rd day, 7th day, 14th day
Rapid closure of the wound.
时间窗: 24 hours, 3rd day, 7th day, 14th day
Rapid bone formation thus with a greater amount of density and mineral content
时间窗: 24 hours, 3rd day, 7th day, 14th day
次要结局
- 1) Early epithelialisation of the wound.(2) reduction in pain .)
研究者
Vaibhav Sheshrao Bibe
Meenakshi Ammal Dental college and Hospital, Chennai