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Medicina
Volume 62
Issue 7
10.3390/medicina62071299
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

Topical Pregabalin in Burning Mouth Syndrome: A Real-World Study of Peripheral Neuromodulation

by
Federica Canfora
1,*,
Antonietta Argiuolo
2,
Simona Salerno
1,
Claudia Castellucci
1,
Roberta Evangelista
1,
Salvatore Ferrara
1,
Rosa Valletta
1,
Alfredo De Rosa
3,
Lucia Memè
3,
Michele Davide Mignogna
1 and
Daniela Adamo
1,3
1
Department of Neurosciences, Reproductive Sciences and Odontostomatology, University of Naples “Federico II”, 80131 Naples, Italy
2
Departmental Program of Clinical Psychopathology, Federico II University Hospital, 80131 Naples, Italy
3
Department of Life Science, Health and Health Professions, Link Campus University, 00165 Rome, Italy
*
Author to whom correspondence should be addressed.
Medicina 2026, 62(7), 1299; https://doi.org/10.3390/medicina62071299 (registering DOI)
Submission received: 1 May 2026 / Revised: 16 June 2026 / Accepted: 25 June 2026 / Published: 5 July 2026
(This article belongs to the Special Issue New Advances in Oral Care)
Versions Notes

Abstract

Background and Objectives: Burning Mouth Syndrome (BMS) remains a challenging condition to manage, as current treatments show variable efficacy and are often limited by tolerability, particularly in older and medically complex patients. This has prompted interest in topical neuromodulatory strategies targeting peripheral mechanisms while minimizing systemic exposure, with topical pregabalin emerging as a potential option. Materials and Methods: In this prospective longitudinal real-world study, 100 patients with BMS treated at a tertiary referral center received topical pregabalin as an off-label intraoral swish-and-spit solution. Patients were assessed at baseline and after 3 months using validated measures of pain intensity (VAS), qualitative pain perception (SF-MPQ), anxiety (HAM-A), depression (HAM-D), sleep quality (PSQI, ESS), and global clinical severity (CGI-S). Results: After 3 months, median VAS decreased from 8 (IQR 7–9) to 5 (IQR 4–6) and SF-MPQ from 10 (IQR 7–17) to 6.5 (IQR 4–10) (both p < 0.001), with concurrent improvements in anxiety, depressive symptoms, and clinical severity. Overall, 46% of patients achieved ≥30% pain reduction, while 73% and 16% reached ≥20% and ≥50% reductions, respectively. Higher baseline pain predicted greater improvement. No serious adverse events were reported. Conclusions: These findings suggest that topical pregabalin may represent a safe and potentially effective option for BMS, although controlled studies are required to confirm its efficacy.
Keywords: Burning Mouth Syndrome; pregabalin; topical therapy; neuropathic pain; chronic oral pain; real-world study; Visual Analog Scale; anxiety; depression; sleep disturbance; neuromodulatory treatment Burning Mouth Syndrome; pregabalin; topical therapy; neuropathic pain; chronic oral pain; real-world study; Visual Analog Scale; anxiety; depression; sleep disturbance; neuromodulatory treatment

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MDPI and ACS Style

Canfora, F.; Argiuolo, A.; Salerno, S.; Castellucci, C.; Evangelista, R.; Ferrara, S.; Valletta, R.; De Rosa, A.; Memè, L.; Mignogna, M.D.; et al. Topical Pregabalin in Burning Mouth Syndrome: A Real-World Study of Peripheral Neuromodulation. Medicina 2026, 62, 1299. https://doi.org/10.3390/medicina62071299

AMA Style

Canfora F, Argiuolo A, Salerno S, Castellucci C, Evangelista R, Ferrara S, Valletta R, De Rosa A, Memè L, Mignogna MD, et al. Topical Pregabalin in Burning Mouth Syndrome: A Real-World Study of Peripheral Neuromodulation. Medicina. 2026; 62(7):1299. https://doi.org/10.3390/medicina62071299

Chicago/Turabian Style

Canfora, Federica, Antonietta Argiuolo, Simona Salerno, Claudia Castellucci, Roberta Evangelista, Salvatore Ferrara, Rosa Valletta, Alfredo De Rosa, Lucia Memè, Michele Davide Mignogna, and et al. 2026. "Topical Pregabalin in Burning Mouth Syndrome: A Real-World Study of Peripheral Neuromodulation" Medicina 62, no. 7: 1299. https://doi.org/10.3390/medicina62071299

APA Style

Canfora, F., Argiuolo, A., Salerno, S., Castellucci, C., Evangelista, R., Ferrara, S., Valletta, R., De Rosa, A., Memè, L., Mignogna, M. D., & Adamo, D. (2026). Topical Pregabalin in Burning Mouth Syndrome: A Real-World Study of Peripheral Neuromodulation. Medicina, 62(7), 1299. https://doi.org/10.3390/medicina62071299

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