Efficacy of Albumin Platelet Rich Fibrin on Complications After Mandibular Third Molar Extraction: A Clinical and Biochemical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Assessment of Facial Swelling (Edema): in Centimeters
研究概览
简要总结
Sixteen patients with bilateral impacted lower third molars seeking treatment will be recruited from the out-patient clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry at Mansoura University.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy patients classified as ASA (American Society of Anesthesiologists) Physical Status Classification Class I.
- •Patients seeking extraction of both mandibular third molars.
- •Patients aged 18 - 40 years old by the day of surgery.
- •Patients willing to participate in the study and commit to regular follow-up appointments.
排除标准
- •Heavy Smokers (more than 25 cigarettes per day).
- •Patients with Poor oral hygiene.
- •Patients with history of a chemotherapy or radiotherapy
研究组 & 干预措施
Control: No Autologous Albumin Gel applied Side
Surgical extraction of impacted third molar without autologous albumin gel application.
干预措施: Surgical extraction of impacted third molar (Procedure)
Study: Autologous Albumin Gel applied Side
Surgical extraction of impacted third molar with autologous albumin gel application.
干预措施: Alb-PRF Autologous Albumin Gel (Device)
结局指标
主要结局
Assessment of Facial Swelling (Edema): in Centimeters
时间窗: first day, third day and seventh day
Measurements will be taken before surgery (baseline). Swelling will be evaluated by comparing the difference between preoperative and postoperative measurements. Swelling will be evaluated in Centimeters using a tape measure. Performed on the patient's operated site using these reference points: * A) Lateral corner of the eye/angle of the mandible * B) Tragus/outer corner of the mouth * C) Tragus/soft tissue pogonion
Wound Healing: Disturbed/Not Disturbed
时间窗: first day, third day and seventh day
The area of operation will be examined for Any manifestations of wound healing disturbance including: * Swelling, redness, hotness, pus discharge, signs and symptoms of infection, Wound dehiscence * Exposure of underlying hard tissue will be carefully noted
Postoperative pain severity assessment : using a 10 point Visual Analogue Scale (VAS)
时间窗: first day, third day and seventh day
Pain will be evaluated using Visual Analogue Scale (VAS). Which is a 10 point scale, in which the minimum end '0" represents no pain, while the maximum end 10" represents the worst pain.
Laboratory Assessments of multiple blood/Biochemical markers and their concentrations
时间窗: first day, third day and seventh day
First 5 cm of blood will be withdrawn under aseptic conditions using sterile venipuncture, then blood will be separated immediately by centrifugation (3000 rpm). To be assessed using enzyme-linked immunosorbent assays (ELISA) kits according to the manufacturer's protocol for their Serum concentrations of: interleukin 6, macrophage inflammatory protein, granulocyte macrophage colony-stimulation factor, and vascular endothelial growth factor
Assessment of Facial Swelling (Edema)
时间窗: first day, third day and seventh day after surgery
Swelling will be evaluated using a tape measure with three measurements performed on the patient's operated site using five reference points: * A) Lateral corner of the eye/angle of the mandible * B) Tragus/outer corner of the mouth * C) Tragus/soft tissue pogonion * Measurements will be taken before surgery (baseline). Swelling will be evaluated by comparing the difference between preoperative and postoperative measurements.
Wound Healing
时间窗: first day, third day and seventh day
The area of operation will be examined for signs and symptoms of infection, including: swelling, redness, hotness, pus discharge. * Any manifestations of wound healing disturbance, including: * Wound dehiscence * Exposure of underlying hard tissue will be carefully noted
3- Postoperative pain severity
时间窗: first day, third day and seventh day
Pain will be evaluated using Visual Analogue Scale (VAS) which is a 10- points (cm) scale, in which the minimum end '0" represents no pain, while the maximum end 10" represents the worst pain. Patients, after being informed about the VAS by the operator, identified the VAS score and the operator recorded them in their charts.
4- blood test
时间窗: first day, third day and seventh day
1. 5 cm of blood will be withdrawn under aseptic conditions using sterile venipuncture. 2. Blood will be separated immediately by centrifugation (3000 rpm). 3. Serum samples will be frozen at -20°C until assay. 4. Serum concentrations of interleukin 6, macrophage inflammatory protein, granulocyte macrophage colony-stimulation factor, and vascular endothelial growth factor will be assessed using enzyme-linked immunosorbent assays (ELISA) kits according to the manufacturer's protocol.
次要结局
未报告次要终点
研究者
Nader Matrouk Farag AL-Saihani
Clinical Demonstrator at oral and maxillofacial surgery department, Faculty of dentistry, Mansoura University, Mansoura University
Mansoura University