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临床试验/CTRI/2025/05/087250
CTRI/2025/05/087250尚未招募不适用

Clinical outcomes of exercise physiotherapy interventions with and without LASER therapy in conservative oral submucous fibrosis management: A randomized control trial

MULTIDISCIPLINARY RESEARCH UNIT SHRI M P SHAH GOVERNMENT MEDICAL COLLEGE JAMNAGAR1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2025年2月6日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
33
试验地点
1
主要终点
Pain Reduction

研究概览

简要总结

This randomized controlled trial aims to evaluate the clinical outcomes of exercise physiotherapy interventions with and without LASER therapy in the conservative management of oral submucous fibrosis Participants diagnosed with OSMF will be randomly assigned to either the Exercise Physiotherapy Only group or the Exercise Physiotherapy with LASER Therapy group. The intervention will be conducted over a predefined period, with assessments at baseline and post-intervention. Primary outcomes include mouth opening and pain reduction. Data will be analyzed using paired t-tests or Wilcoxon signed-rank tests for within-group comparisons and independent t-tests or Mann-Whitney U tests for between-group comparisons, based on data normality. Effect sizes will be estimated to determine clinical significance. A p-value less than 0.05 will be considered statistically significant. The study aims to provide evidence on the effectiveness of LASER therapy as an adjunct to exercise physiotherapy in improving mouth opening and reducing pain in OSMF patients. Findings from this study will contribute to evidence-based recommendations for non-surgical management strategies in OSMF.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Not Applicable

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 diagnosed with OSMF based on clinical and histopathological findings Interincisal mouth opening less than 35mm Willingness to participate and provide informed consent Have not undergone any surgical intervention before Have quit the habit for more than 6 months.

排除标准

  • Patients with associated malignancies Have undergone any surgical procedure involving face and jaws Contraindications to laser therapy or inability to perform physiotherapy exercises.

结局指标

主要结局

Pain Reduction

时间窗: Baseline | Post intervention at 4 weeks

Mouth Opening

时间窗: Baseline | Post intervention at 4 weeks

次要结局

未报告次要终点

研究者

发起方
MULTIDISCIPLINARY RESEARCH UNIT SHRI M P SHAH GOVERNMENT MEDICAL COLLEGE JAMNAGAR
申办方类型
Government funding agency

研究点 (1)

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