NOVEL INTERVENTIONS IN OSMF TREATMENT: COMPARING PHARMACOLOGICAL AND SURGICAL MODALITIES THROUGH A TRIPLE-ARM CLNICAL TRIAL
试验速览
- 阶段
- Phase 3 4
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mouth opening in mm
研究概览
简要总结
oral submucous fibrosis is a chronic disease characterised by progressivefibrosis of the oral mucosa leading to restructed mouth opening burning sensation and difficulty in eating and speaking. It is strongly associated with areca nut chewing and is prevelant in south aisa. The condition significantly reduces the patient’s quality of life and can have long term effects if left untreated. the study evaluates three treatment modalities for osmf to determine their effectiveness in improving mouth opening and reducing symptoms like burning sensation. 60 patients will be divided into three groups. Group 1 have weekly traimcinolone injections for six weeks. Group 2 have PRP for 6 weeks. Group 3 have Surgical fibrotomy with buccal fat pad reconstruction. Patiens will be assessed for moth opening improvementsand burning sensation over 6 months with long term follow up evaluating quality of life using Oral Health Impact Profile 14 Questionnairefor more than one year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 53.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with an interincisal mouth opening between 15 to 25mm Biopsy proven OSMF No systemic disorders Patients with hemoglobin greater than 10g per dl and platelet count greater than 150000 per microlitre Patients aged between 18 to 53 years Patients who have quit tobacco use more than 6 months ago Patients willing to take part in the study Available for the long term follow up.
排除标准
- •Patients with an interincisal mouth opening less than 15 mm Patients with age less than 18 years and greater than 53 years Currently chewing tobacco or less than 6 months of quitting of habit Smokers Patients having allergy to local drugs Patients who have undergone any kind of treatment for OSMF previously Patients with an uncontrolled systemic illness Patients with altered hemodynamic values Patients who have undergone treatment for malignancy any radiotherapy or chemotherapy Women who are pregnant lactating or taking oral contraceptives Patients who have reduced mouth opening due to reasons other than OSMF Patients who are not willing to participate in the study.
结局指标
主要结局
Mouth opening in mm
时间窗: Mouth opening in mm | Reduction in the burning sensation will be assessed by visual analogue scale
Reduction in the burning sensation will be assessed by visual analogue scale
时间窗: Mouth opening in mm | Reduction in the burning sensation will be assessed by visual analogue scale
次要结局
- Quality of life using Oral Health Impact Profile 14 Questionnaire(Follow up for more than 12 months)
研究者
Dr SHARIQUE TANVEER
DEPARTMENT OF ORAL AND MAXILLOFACIAL SURGERY GOVERNMENT DENTAL COLLEGE AND HOSPITAL JAMNAGAR