Status:
COMPLETED
Topical Amitriptyline 1% Gel for the Treatment of Burning Mouth Syndrome
Lead Sponsor:
Universidad de Murcia
Conditions:
Burning Mouth Syndrome
Stomatodynia
Eligibility:
All Genders
18+ years
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...
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...
Eligibility Criteria
Inclusion
- 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
- 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, ).
Key Trial Info
Start Date :
January 2 2024
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 30 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT07214181
Start Date
January 2 2024
End Date
May 30 2025
Last Update
October 9 2025
Active Locations (1)
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1
Clinica Odontologica Universitaria
Murcia, Murcia, Spain, 30008