Comparative evaluation of Injection dexamethasone with Hyaluronidase and Injection Platelet Rich Plasma (PRP) in Management of Oral Submucous Fibrosis (OSMF)- A randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Efficacy of Triamcinolone acetonide with hyaluronidase injection versus Platelet rich plasma injection in OSMF patients in parameters as 1.Mouth opening (Inter-incisal distance IID)
研究概览
简要总结
Oral submucous fibrosis (OSMF) is a potentially malignant condition of the oral cavity resulting in increasing loss of tissue mobility, marked rigidity, and eventual restricted ability to open the mouth. It may progressively affect the entire oral cavity, and occasionally the pharynx. It has a strong link to areca nut (betel nut) chewing. The other proposed etiological factors include excessive chilly consumption, vitamin B12 and iron deficiency, tobacco ingestion, smoking, autoimmunity, and genetic and environmental factors.
Treatment of oral submucous fibrosis is based on medical and surgical management along with physiotherapy, Conventional medical management includes avoidance of irritating substances like betel chewing, tobacco ingestion or smoking, etc., and involves regular administration of corticosteroids, either via submucosal injections or topical application. Corticosteroids have been considered the first-choice agent for the management of OSMF, However, continuous and prolonged use is associated with many systemic adverse effects such as bad taste, nausea, facial swellings, dryness, mucosal atrophy, candidal infection, granuloma formation, hypersensitivity reactions, delayed wound healing, and in later stages; hypothalamus pituitary adrenal suppression. Therefore, it is the need of an hour to establish an effective and efficient treatment modality for OSMF with lesser or no adverse effects.
Platelet-rich plasma is the autologous component of the plasma and contains higher concentrations of platelets, growth factors, and cytokines than the basal level. Platelet-rich plasma (PRP) is a simple, efficient, and minimally invasive method. Platelet-rich plasma is an element of whole blood, prepared through centrifugation to a concentrated form. Platelet-rich plasma acts by inducing the platelets to secrete pro-inflammatory mediators and growth factors. These, in turn, initiate the cascade of wound healing and bring about tissue remodeling.
This randomized controlled trial aims to compare the efficacy of the Injection dexamethasone and Hyaluronidase with the Injection of platelet-rich plasma (PRP) in the Management of Oral Submucous Fibrosis. By assessing parameters such as Mouth Opening (Interincisal distance), Burning Sensation (VAS Score), and Cheek flexibility. The study aims to evaluate the potential of PRP in alleviating symptoms and improving the condition of patients with OSMF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator 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
- •Patients with age greater than 18 years and of either gender 2) Individuals with clinically diagnosed oral submucous fibrosis in stages I II and III (according to the classification of Nagesh and Bailoor 1993) 3) Patients who are willing to participate in the study.
排除标准
- •Patients who did not give consent for participation.
- •Patients in which steroids are contraindicated.
- •Patients with systemic disorders.
- •(Patients on anticoagulant therapy diabetes mellitus hypertension bronchitis) 4) Patients with severely reduced mouth-opening 5) Pregnant women and lactating mothers.
结局指标
主要结局
Efficacy of Triamcinolone acetonide with hyaluronidase injection versus Platelet rich plasma injection in OSMF patients in parameters as 1.Mouth opening (Inter-incisal distance IID)
时间窗: The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.
2.Burning sensation and pain
时间窗: The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.
3.cheek flexibility
时间窗: The patient will be assessed for the parameters before and after each session of intralesional injections and followed up monthly for 3 months by recalling the patient.
次要结局
未报告次要终点
研究者
Dr Sneha Sarang
Sinhgad dental college and hospital, Pune
