Observational studyJournal of oral rehabilitation2026
Effectiveness and Tolerability of Topical Amitriptyline 10% Plus Lidocaine 2% Gel in Adults With Post-Traumatic Trigeminal Neuropathic Pain: A Real-World Evidence Study.
Observational study in Journal of oral rehabilitation, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers, 1 of them a synthesis that pooled it.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
2 citing papers in PubMed, 1 synthesis or guideline pooled it.
- The Role of the Antidepressants in Managing Chemotherapy-Induced Neuropathic Pain: A Systematic Review.Pharmacology research & perspectives · 2026Pooled it
- Retrospective Evaluation of the Topical Use of 1% Amitriptyline in Patients with Burning Mouth Syndrome.Dentistry journal · 2026Article
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundPost-traumatic trigeminal neuropathic pain (PTNP) is a debilitating orofacial pain disorder most commonly caused by trigeminal nerve injury after dental procedures or facial trauma. Available systemic therapies have modest and inconsistent efficacy, with substantial tolerability concerns limiting adherence.
objectivesTo evaluate the real-world effectiveness and tolerability of a compounded intraoral mucoadhesive gel containing amitriptyline 10% plus lidocaine 2% in adults with PTNP.
methodsThis retrospective real-world evidence study included adults with PTNP meeting ICHD-3/ICOP criteria who were treated at a tertiary orofacial pain clinic from May 1, 2023, to April 30, 2024. The primary outcome was the within-patient change in pain intensity on a 0-10 numerical rating scale (NRS) from baseline to week 8. Secondary outcomes included responder rates (≥ 50% and ≥ 30% pain reduction), patient global impression of improvement (PGI-I) and adverse events (AEs).
resultsOf 94 patients identified, 40 were included in the complete-case initiator cohort. Mean pain intensity decreased from 6.3 ± 1.7 at baseline to 3.0 ± 2.7 at week 8, corresponding to a mean within-patient reduction of 3.30 points (95% CI, 2.51-4.09; p < 0.001). Twenty-two of 40 patients (55%; 95% CI, 40-69) achieved a ≥ 50% reduction in pain intensity, and 27 of 40 (68%; 95% CI, 52-80) achieved a ≥ 30% pain reduction. Seventy-five percent (30/40, 95% CI, 60-86) reported overall improvement on the PGI-I. Mild treatment-related AEs occurred in five of 40 patients (12%); no serious AEs or treatment discontinuations were reported.
conclusionIn this retrospective real-world study, topical amitriptyline-lidocaine mucoadhesive gel was associated with statistically significant and clinically meaningful pain improvement in adults with PTNP, together with favourable tolerability. These findings support targeted mucosal delivery as a promising local therapeutic option and potential medication-sparing strategy, particularly when systemic therapies are ineffective or poorly tolerated. Randomized controlled trials are now needed to confirm efficacy and clarify the role of topical amitriptyline in PTNP treatment pathways and routine clinical care.
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