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临床试验/CTRI/2025/08/093396
CTRI/2025/08/093396已完成2 期

Assessment of the efficacy of Yashtimadhvadi Pratisarna (Toothpaste) in reducing Dantaharsha (Dentinal Hypersensitivity)-A Clinical and Scanning Electron Microscopic Study

Government Ayurved College Nagpur1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年9月15日最近更新:

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Reduction in dentinal hypersensitivity (Dantaharsha) as measured by Visual Analog Scale (VAS) scores after application of Yashtimadhwadi Pratisarana.

研究概览

简要总结

Dantaharsha (Dentinal Hypersensitivity) is a common dental complaint characterized by sharp pain in response to thermal, chemical, or tactile stimuli due to exposed dentinal tubules. The present clinical study aims to evaluate the efficacy of Yashtimadhwadi Pratisarana (Ayurvedic toothpaste prepared from Yashtimadhu-based formulation) in reducing dentinal hypersensitivity. Eligible participants will be randomly allocated to receive the intervention for 4 weeks, with assessment of pain reduction using the Visual Analog Scale (VAS) at baseline and post-intervention. The study also includes evaluation of changes in dentinal tubule occlusion through clinical examination (and Scanning Electron Microscopy if applicable). The trial is designed as a single-center, prospective clinical study conducted in the Department of Shalakyatantra, GOVT.AYURVED COLLEGE Nagpur, India.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Patients having dentinal hypersensitivity at least in 2 teeth, having minimum 16 natural teeth free of large restoration or prosthetic crown, at least two teeth showing painful response using dental explorer.

排除标准

  • Teeth with severe caries, faulty restoration, prosthetic crown, chipping, fracture, symptoms of pulpal damage Participants who has taken long term analgesic therapy within 30 days before the start of the study Participants who have undergone any treatment for dentinal hypersensitivity in past 3 months Participants with ongoing orthodontic therapy Participants with history or presence kidney disorder, kidney stones, eating disorders, uncontrolled gastro-oesophageal reflux disease, excessive exposure to acids or any other systemic condition that predisposes to dentinal hypersensitivity Severe Periodontal disease characterized by extensive tooth mobility and or extensive alveolar bone loss involving 10 or more teeth Women who are pregnant or lactating.

结局指标

主要结局

Reduction in dentinal hypersensitivity (Dantaharsha) as measured by Visual Analog Scale (VAS) scores after application of Yashtimadhwadi Pratisarana.

时间窗: At baseline and after 4 weeks

Evaluation of changes in clinical symptoms (cold, sweet, sour stimuli response)

时间窗: At baseline and after 4 weeks

次要结局

  • Evaluation of dentinal tubule occlusion through SEM analysis before and after intervention(Baseline (Day 0) and after completion of intervention (Week 4).)

研究者

发起方
Government Ayurved College Nagpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

DR SARIKA PALVE

Bhausaheb Mulak Ayurved College And RH Butibori Nagpur

研究点 (1)

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