Mineral-ionic Magnesium/Calcium Oral Rinse (THERAVEX® Total Oral Care Plus) in Primary Burning Mouth Syndrome: a Double-blind Randomized Placebo-controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Change in Burning Pain Intensity (Numeric Rating Scale, NRS)
研究概览
简要总结
In this randomized, double-blind, placebo-controlled trial, 116 adults with primary BMS were assigned (1:1) to receive THERAVEX® Total Oral Care Plus or placebo for 8 weeks. Participants rinsed 10 mL for 60 seconds three times daily. The primary outcome was change in burning pain intensity (Numeric Rating Scale, NRS). Secondary outcomes included responder rate (≥2-point NRS reduction), Oral Health Impact Profile-14 (OHIP-14), Xerostomia Inventory, Patient Global Impression of Change (PGIC), and safety assessments.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Quadruple : Participant, Care Provider, Investigator, Outcomes Assessor
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults aged ≥18 years. Diagnosis of primary Burning Mouth Syndrome (BMS) according to International Classification of Orofacial Pain (ICOP) and ICHD-3 criteria.
- •Daily intraoral burning or dysaesthetic sensation persisting for ≥3 months and occurring ≥2 hours per day.
- •Clinically normal oral mucosa without visible lesions. Absence of identifiable local or systemic causes of oral burning following standard diagnostic workup.
- •Ability and willingness to comply with study procedures and provide written informed consent.
排除标准
- •Presence of secondary causes of oral burning (e.g., oral candidiasis, nutritional deficiencies, uncontrolled diabetes mellitus, thyroid disorders).
- •Autoimmune diseases affecting the oral cavity (e.g., Sjögren syndrome). Active oral mucosal pathology or lesions. Pregnancy or breastfeeding. Known hypersensitivity to any component of the study product. Use of topical clonazepam, capsaicin, systemic neuromodulators, or other treatments for BMS within 14 days prior to enrollment.
- •Severe psychiatric disorders or conditions that could interfere with study participation or outcome assessment.
研究组 & 干预措施
THERAVEX® Total Oral Care Plus (Mineral-Ionic Oral Rinse)
干预措施: THERAVEX® Total Oral Care Plus (Device)
Placebo Oral Rinse
干预措施: THERAVEX® Total Oral Care Plus (Device)
结局指标
主要结局
Change in Burning Pain Intensity (Numeric Rating Scale, NRS)
时间窗: 8 weeks
Change in intraoral burning pain intensity from baseline to Week 8, measured using an 11-point Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain). Participants reported their average daily pain over the preceding week at each assessment time point.
次要结局
未报告次要终点