CTRI/2025/07/090358尚未招募3 期
Comparative evaluation of Jasmate® Mouthwash and Biotene® Gel in burning mouth conditions- a randomized clinical trial
Dr. D. Y. Patil Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年7月15日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in VAS score for burning mouth sensation
研究概览
简要总结
This randomized clinical trial aims to compare the efficacy of Jasmate® Mouthwash and Spray with Biotene® Oral Balance Gel in patients with burning mouth syndrome associated with xerostomia. Forty participants will be randomly assigned to two groups. Evaluations will include VAS score for symptom relief, saliva flow rate, DryTraq™ lateral flow test, swallowing function (WST, EAT-10), and quality of life (OHIP-14, SWAL-QoL). The study is double-blinded, placebo-controlled, and conducted over one month with six-month follow-up for adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults with clinically diagnosed burning mouth condition VAS score 4–10 Able to give informed consent.
排除标准
- •Systemic diseases affecting saliva production History of allergy to ingredients Concurrent participation in another clinical trial.
结局指标
主要结局
Change in VAS score for burning mouth sensation
时间窗: Day 1, Day 8, Day 15, Day 29
次要结局
- OHIP-14 score changes
- Swallowing function (WST, EAT-10)(Day 1, Day 8, Day 15, Day 29)
- DryTraq test results(Day 1, Day 8, Day 15, Day 29)
- SWAL-QoL scores(Day 1, Day 8, Day 15, Day 29)
研究者
Dr Sunil Surendraprasad Mishra
Dr. D. Y. Patil Dental College and Hospital
研究点 (1)
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