Last reviewed · How we verify
NCT07214181: TOP-AMI → TOPi
Topical Amitriptyline 1% Gel for the Treatment of Burning Mouth Syndrome
trial testing Topical amitriptyline 1% gel in Burning Mouth Syndrome in 30 participants. Completed in 30 May 2025.
30 November 2024
Quick facts
| Lead sponsor | Universidad de Murcia |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 30 |
| Start date | 2 January 2024 |
| Primary completion | 30 November 2024 |
| Estimated completion | 30 May 2025 |
| Sites | 1 location across Spain |
Drugs / interventions tested
- Topical amitriptyline 1% gel — full drug profile →
Conditions studied
- Burning Mouth Syndrome — all drugs for Burning Mouth Syndrome →
- Stomatodynia — all drugs for Stomatodynia →
Sponsor
Universidad de Murcia — full company profile →
Who can join
18 and older, any sex, with Burning Mouth Syndrome or Stomatodynia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT07214181
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Burning Mouth Syndrome
Currently open trials in the same condition.
- NCT07016555 — Burning Mouth Syndrome: Symptoms and Management · EARLY_PHASE1 · recruiting
- NCT07381361 — Photobiomodulation Therapy vs. Alpha-Lipoic Acid in Burning Mouth Syndrome Treatment · NA · active not recruiting
- NCT06040190 — Effect of Treatments on Pain and Quality of Life in Individual With Burning Mouth Syndrome · Phase 4 · recruiting
- NCT05819697 — Reducing Patient Memory Recall in the Burning Mouth Patient Population · recruiting
Other Universidad de Murcia trials
Trials by the same sponsor.
- NCT07310459 — Perinatal Risk Factors in Motor Development · not yet recruiting
- NCT06982456 — Manual Therapy Techniques for Cervical Pain: Algometric Evaluation · NA · enrolling by invitation
- NCT06910150 — Effectiveness of a Session of Analgesic Electrostimulation (Invasive and Non-invasive) Applied to the Quadriceps Muscle · NA · enrolling by invitation
- NCT06206499 — Laterally Rotated Flap for Soft Tissue Augmentation Around Maxillary Loaded Osseointegrated Dental Implant · NA · unknown
- NCT06240416 — Autogenous Particles Harvesting During Implant Surgery · NA · unknown
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT07214181 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Universidad de Murcia
- Last refreshed: 9 October 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT07214181.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing