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Completed

NCT Number: NCT07214181

Topical Amitriptyline 1% Gel for the Treatment of 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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinica Odontologica Universitaria

Murcia, 30008, Spain

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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, ).

Treatment and study plan

Topical amitriptyline 1% gel

Drug

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.

Primary outcomes

  1. Title: Change in mean pain intensity (NRS 0-10)

    Time frame: 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 outcomes

  1. Patient Global Impression of Improvement (PGI-I)

    Time frame: Time Frame: At 4 weeks

    Description: Patient-reported overall improvement, categorized as "very much better," "much better," "a little better," "no change," or "worse."

Sponsors and collaborators

Lead sponsor

Universidad de Murcia

Other

Registry information

Acronym: TOP-AMI → TOPi

Important dates

Study start
2024
Primary completion
2024
Study completion
2025
First posted
Oct 9, 2025
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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