Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 804
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
PRF in orabase will be applied as a pack material on chronic oral ulcers of chronic multiple oral lesions compared to conventional topical steroid therapy with clobetasol propionate 0.05% in orabase. The outcomes measured are Pain alleviation as Primary outcome and Clinical improvement in terms of Ulcer size, Number and Mucositis score as Secondary outcomes. Time frame for outcomes assessment will be Daily for 7 Days regarding pain score and weekly for 2 weeks regarding clinical improvement.
详细描述
The management of oral ulcers and mucositis specially the resistant types such as oral ulcers due to auto-immune diseases is a major concern by the dentists through all the world. Topical corticosteroids, analgesics, Laser bio modulation all have been proposed as treatments with limited efficacy in many cases. There are few number of clinical trials on Plasma preparation in management of oral mucositis and oral ulcers. Platelet rich fibrin (PRF) is one of the platelet concentrates. The preparation protocol of PRF is simple and easy, could be prepared autologous and immediately placed on the oral ulcers and mucositis.
Subjects and Methods: A non Randomized clinical trial will be conducted. Ten patients with different resistant oral ulcers and mucositis were enrolled. all with grade 4 WHO mucositis score. The initial numerical ratting score of pain is 10. For all patients 20 ml blood sample will obtained in plain blood vacutainer, centrifuged for 15 minutes on 3000 rpm. The resultant gel, obtained and squeezed to prepare a membrane, the membrane will be mixed with orabase and placed over the oral ulcers and mucositis over a piece of gauze. The patients will be instructed not to eat or drink for 2 hours after application. The remaining serum after squeezing was mixed with equal amount of orabase and used topically on the oral mucositis and ulcers.
Clobetasol Propionate 0.05% in orabase will be applied to 10 control patients 3 times per day for one week.
The steps will be repeated after one week if the patients' symptomatic scores for WHO and numerical rating score were not zero.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with Oral ulcers due to Benin mucous membrane pemphioid, Pemphius vulgaris and Steven Johnson's Syndrome with mucositis score 4 and pain score 10
排除标准
- •patients with any systemic other systemic condition
研究组 & 干预措施
autologous Platelet rich fibrin in Orabase (PRF)
applied to oral ulcer and/or mucositis 3 times per day
干预措施: Platelet rich fibrin gel in Orabase (Biological)
Clobetasol propionate 0.05%(Dermovate cream) in orabase
applied to oral ulcer and/or mucositis 3 times per day
干预措施: Dermovate cream in Orabase (Drug)
结局指标
主要结局
Pain score
时间窗: 1 week
Numerical Rating score of Pain, graded from 0 to 10, were 0 is no pain at all and 10 represent severe pain, obtaining lower values reflects improvement
次要结局
- Mucositis(2 weeks)
- ulcer size(2 weeks)
- ulcer number(2 weeks)
研究者
Eman Magdy Ahmed
Lecturer of Oral Medicine and Dianosis
Beni-Suef University