Topical Amitriptyline 1% Gel for the Treatment of Burning Mouth Syndrome

Completed

• Conditions: Burning Mouth Syndrome; Stomatodynia
• Interventions: Drug: Topical amitriptyline 1% gel

• Registration Number: NCT07214181
• Lead Sponsor: Universidad de Murcia

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2024-01-02
• Primary Completion: 2024-11-30
• Study Completion: 2025-05-30
• Status Verified: 2025-10
• Study First Submitted: 2025-10-02
• Study First Submitted QC: 2025-10-02
• Last Update Submitted: 2025-10-02
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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.

Exclusion Criteria

• 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, ).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
This retrospective cohort includes patients diagnosed with burning mouth syndrome (BMS	Topical amitriptyline 1% gel	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.

Primary Outcome Measures

Name	Time	Method
Title: Change in mean pain intensity (NRS 0-10)	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.

Secondary Outcome Measures

Name	Time	Method
Patient Global Impression of Improvement (PGI-I)	Time Frame: At 4 weeks	Description: Patient-reported overall improvement, categorized as "very much better," "much better," "a little better," "no change," or "worse."

Trial Locations

Locations (1)

Clinica Odontologica Universitaria; 🇪🇸 Murcia, Murcia, Spain