A comparative study of efficacy of Therapeutic Ultrasound therapy and Intralesional Injection in patients with oral submucous fibrosis - a clinical trial study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The study aims to determine which treatment therapy, along with regular mouth opening exercises and a cessation of the betel quid chewing habit, will proven to be essential for managing OSMF cases in both the early and severe stages of advancement.
研究概览
简要总结
The goal of this study is to assess the effects of intralesional injection of dexamethasone, hyaluronidase and adjuvant therapeutic ultrasonography with physical therapy and in the treatment of persons with oral submucous fibrosis. To assess the effectiveness of intralesional injection and ultrasound therapy in patients with oral submucous fibrosis. Thirty patients selected who met the inclusion criteria with all age group and clinically diagnosed with oral submucous fibrosis were included in the study. Exclusions from the study were patients having a history of radiation therapy, OSMF medication or surgery, systemic sclerosis, tetany, or other systemic diseases. Prior to the study’s commencement, institutional ethical committee approval was acquired. Every participant in this study provided written informed permission. After meeting the inclusion and exclusion criteria, the patients who were chosen for the study were divided into groups A and B based on the sequence created by the software. Fifteen OSMF patients in Group A received injections of dexamethasone (4 mg/ml) and 1500 IU of hyaluronidase. Group B comprises 15 OSMF patients who received physical activity and therapeutic ultrasound treatment. Patients will have intralesional injections and ultrasound therapy application every two weeks for a total of four weeks. Areas for submucosal local injection include the buccal mucosa, pterygomandibular raphae, outer soft palate, and any circumoral bands. Dexamethasone (4 mg/ml) and 1500 IU of hyaluronidase injection. All of the patients received treatment using the same calibrated ultrasound equipment throughout the research [Figure Regarding the ultrasound therapy procedure, ultrasound at a continuous 1:1 duty cycle intensity of 1.5 to 1.8 W/cm2 ,3 MHz for 5–6 minutes while moving a sound head back and forth in the template at a pace of around 4 cm/s to each side over the fibrosis area.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)(—)
- 性别
- Male
入选标准
- •All age group patient.
- •Clinically diagnosed with OSMF.
排除标准
- •The existence of any additional illnesses, such as tetany or systemic sclerosis b.
- •The history of radiation therapy c.
- •The history of OSMF medicinal or surgical treatment d.
- •The existence of systemic disease.
结局指标
主要结局
The study aims to determine which treatment therapy, along with regular mouth opening exercises and a cessation of the betel quid chewing habit, will proven to be essential for managing OSMF cases in both the early and severe stages of advancement.
时间窗: at baseline 4 weeks and 6 months
In individuals with OSMF, the therapeutic ultrasound will show significant impact on all the parameters including cheek flexibility and mouth opening and it will be works well as an adjuvant in conjunction with combination therapy.
时间窗: at baseline 4 weeks and 6 months
次要结局
未报告次要终点
研究者
Dr Nikita Waghmare
SMBT dental college and hospital ghulewadi Sangamner
