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.
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.
Study Type
OBSERVATIONAL
Enrollment
30
Patients diagnosed with burning mouth syndrome received topical amitriptyline 1% gel applied intraorally. The gel was instructed to be placed on the oral mucosa (tongue and/or other symptomatic areas) two times per day for several weeks, without swallowing. Treatment was provided as part of routine clinical care. This retrospective study collected data on pain intensity, patient global impression of improvement, and adverse events to evaluate the real-world effectiveness and tolerability of this topical formulation.
Clinica Odontologica Universitaria
Murcia, Murcia, Spain
Title: Change in mean pain intensity (NRS 0-10)
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.
Time frame: Baseline to 4 weeks after treatment initiation
Patient Global Impression of Improvement (PGI-I)
Description: Patient-reported overall improvement, categorized as "very much better," "much better," "a little better," "no change," or "worse."
Time frame: Time Frame: At 4 weeks
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