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

NCT ID: NCT07214181

Last Updated: 2025-10-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-01-02
• Study Completion Date: 2025-05-30

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.

Conditions

Burning Mouth Syndrome; Stomatodynia

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

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.

Topical amitriptyline 1% gel

Intervention Type: 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.

Interventions

Topical amitriptyline 1% gel

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.

Intervention Type: DRUG

Eligibility Criteria

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, ).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Murcia

OTHER

Sponsor Role: lead

Responsible Party

Pia Lopez Jornet

MD, DDS,PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Clinica Odontologica Universitaria

Murcia, Murcia, Spain

Countries

Spain

References

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.

Reference Type: RESULT

PMID: 33886076 (View on PubMed)

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.

Reference Type: RESULT

PMID: 39177013 (View on PubMed)

Other Identifiers

C.I. EST: 53/25

Identifier Type: -

Identifier Source: org_study_id