Topical Amitriptyline 1% Gel for the Treatment of Burning Mouth Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Title: Change in mean pain intensity (NRS 0-10)
研究概览
简要总结
Burning mouth syndrome (BMS) is a chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life.
This study reviewed the medical records of patients with BMS who were treated with a topical 1% amitriptyline gel. The aim was to evaluate whether this gel could reduce pain and to record any side effects.
Patients applied the gel inside the mouth for several weeks. Pain intensity was measured using a 0-10 scale before and after treatment. We also collected information about patients' overall impression of improvement and any reported adverse events.
By analyzing these retrospective data, we hope to provide real-world evidence on the effectiveness and safety of topical amitriptyline gel as a potential treatment option for patients with burning mouth syndrome.
详细描述
Burning mouth syndrome (BMS) is a chronic oral pain condition that causes a persistent burning or stinging sensation in the mouth, often without visible changes in the tissues. It mostly affects women in midlife and older age and can greatly reduce quality of life.
This study reviewed the medical records of patients with BMS who were treated with a topical 1% amitriptyline gel. The aim was to evaluate whether this gel could reduce pain and to record any side effects.
Patients applied the gel inside the mouth for several weeks. Pain intensity was measured using a 0-10 scale before and after treatment. We also collected information about patients' overall impression of improvement and any reported adverse events.
By analyzing these retrospective data, we hope to provide real-world evidence on the effectiveness and safety of topical amitriptyline gel as a potential treatment option for patients with burning mouth syndrome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria (ICHD-3 and ICOP).
- •Symptoms recurring daily for >50% of the day for at least 3 months.
- •Pain intensity ≥4 on a 0-10 numerical rating scale (NRS) at baseline.
- •Normal appearance of the oral mucosa and normal intraoral clinical examination.
- •Received topical amitriptyline 1% gel as part of routine care.
排除标准
- •Missing or incomplete medical records.Use of other concomitant topical treatments on the oral mucosa during the study period.
- •Change in systemic pain medication while using topical amitriptyline gel.
- •Presence of local conditions and sytemic that could cause burning mouth symptoms (e.g., candidiasis, lichen planus, allergies, ).
研究组 & 干预措施
This retrospective cohort includes patients diagnosed with burning mouth syndrome (BMS
Patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria who received treatment with topical amitriptyline 1% gel. Patients applied the gel intraorally for several weeks as part of routine clinical care. Data collected from medical records included pain intensity (0-10 numerical rating scale) before and after treatment, patient global impression of improvement, and reported adverse events. The cohort reflects real-world use of topical amitriptyline gel for BMS.
干预措施: Topical amitriptyline 1% gel (Drug)
结局指标
主要结局
Title: Change in mean pain intensity (NRS 0-10)
时间窗: Baseline to 4 weeks after treatment initiation
Description: Pain intensity measured using a numerical rating scale (0 = no pain, 10 = worst possible pain). Mean daily score calculated from patient records at baseline (before treatment) and after 4 weeks of topical amitriptyline gel.
次要结局
- Patient Global Impression of Improvement (PGI-I)(Time Frame: At 4 weeks)
研究者
Pia Lopez Jornet
MD, DDS,PhD
Universidad de Murcia