Comparison of Dexamethasone Versus Platelet Rich Plasma Injection for Improving Trismus in Oral Submucous Fibrosis – A Prospective Randomized study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the effect of Dexamethasone versus Platelet Rich Plasma (PRP) injection intraorally for improving trismus with regard to mouth opening in Oral Submucous Fibrosis (OSMF)
研究概览
简要总结
Oral sub mucous fibrosis (OSMF) is a chronic, premalignant condition of the oral mucosa its insidious, chronic disease affecting any part of the oral cavity and sometimes the pharynx. OSMF is also characterized by reduced movement and depapillation of the tongue, blanching and leathery texture of the oral mucosa, progressive reduction of mouth opening, and shrunken uvula. Dysphonia and hearing impairment is also observed in advanced cases . Quality of life (QoL) is severely affected, worsening with increasing stage of the disease. The malignant transformation rate of OSMF has been reported to be in the range of 7–13%, studies with smaller follow up periods report malignant transformation rates ranging from 1.9–9%.
Conventional medical management includes avoidance of irritating substance like betel chewing, tobacco ingestion or smoking etc. and involves regular administration of corticosteroids, either via submucosal injections or topical application . Steroids suppress or prevent inflammatory reactions, also act as immunosuppressive agents. They can prevent fibrosis by decreasing deposition of collagen and fibroblastic proliferation. Steroids such as dexamethasone, triamcinolone, betamethasone, and hydrocortisone have been used in the treatment of OSMF.
Recently platelet rich plasma (PRP) treatment is gaining popularity in oral
and dental surgery. Platelet rich plasma acts by inducing the platelets to secrete proinflammatory mediators and growth factors. These, in turn, initiate the cascade of wound healing and bring about tissue remodeling.
This study is designed to evaluate the effect of Dexamethasone versus platelet rich plasma in improving trismus due to oral submucous fibrosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •1.The patients of either gender will be included 2.with a clinical diagnosis of OSMF, 3.having burning sensation on eating spicy food 4.presence of palpable fibrous bands on the buccal mucosa and having restricted mouth opening.
排除标准
- •1.who had undergone any other treatment for OSMF 2.patients with diabetes mellitus 3.patients on antiplatelet drugs 4.those with temporo-mandibular joint disorders 5.those who were allergic to local drugs 6.pregnant and lactating women • those with trismus due to other causes and those with other pre-malignant lesions like leukoplakia.
结局指标
主要结局
To compare the effect of Dexamethasone versus Platelet Rich Plasma (PRP) injection intraorally for improving trismus with regard to mouth opening in Oral Submucous Fibrosis (OSMF)
时间窗: DAY-1 | WEEK 1 | EVERY WEEK TILL WEEK -8
次要结局
- To compare the effect of Dexamethasone versus Platelet Rich Plasma (PRP) injection intraorally for improving colour of the mucosa, and burning sensation in Oral Submucous Fibrosis (OSMF)(DAY-1)
研究者
Dr Tejashree R
Shri Atal Bihari Vajpayee Medical College and Research Institute