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

NCT07214181 | Completed DMC

• 1 other identifier: C.I. EST: 53/25
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Burning Mouth Syndrome; Stomatodynia

Keywords

pain , Amitriptyline ; treatment

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline to 4 weeks after treatment initiation

Secondary Outcomes (1)

• Patient Global Impression of Improvement (PGI-I)

  Time Frame: At 4 weeks

Study Arms (1)

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.

Drug: Topical amitriptyline 1% gel

Interventions

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.

This retrospective cohort includes patients diagnosed with burning mouth syndrome (BMS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This retrospective study included adult patients diagnosed with burning mouth syndrome (BMS) according to international diagnostic criteria. All patients received topical amitriptyline 1% gel as part of routine clinical care and had complete medical records with baseline and 4-week follow-up data available for analysis.

You may qualify if:

• 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.

You may not qualify if:

• 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, ).

Sponsors & Collaborators

• Universidad de Murcia: lead

Study Sites (1)

Clinica Odontologica Universitaria

Murcia, Murcia, 30008, Spain

Location

Related Publications (2)

• Kung CP, Sil BC, Zhang Y, Hadgraft J, Lane ME, Patel B, McCulloch R. Dermal delivery of amitriptyline for topical analgesia. Drug Deliv Transl Res. 2022 Apr;12(4):805-815. doi: 10.1007/s13346-021-00982-x. Epub 2021 Apr 22.

  PMID: 33886076 RESULT

• Lebel A, Da Silva Vieira D, Boucher Y. Topical amitriptyline in burning mouth syndrome: A retrospective real-world evidence study. Headache. 2024 Oct;64(9):1167-1173. doi: 10.1111/head.14818. Epub 2024 Aug 23.

  PMID: 39177013 RESULT

MeSH Terms

Conditions

Burning Mouth Syndrome; Stomatodynia; Pain

Interventions

Amitriptyline; Gels

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dibenzocycloheptenes; Benzocycloheptenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Colloids; Complex Mixtures; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Target Duration: 4 Weeks
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, DDS,PhD

Study Record Dates

• First Submitted: October 2, 2025
• First Posted: October 9, 2025
• Study Start: January 2, 2024
• Primary Completion: November 30, 2024
• Study Completion: May 30, 2025
• Last Updated: October 9, 2025

Record last verified: 2025-10

Locations

ES (1)