Custom Delivery Trays for Targeted Topical Corticosteroid Therapy in Autoimmune Gingival Diseases: A Proof-of-Concept Clinical Study

Background: This proof-of-concept clinical study evaluated the feasibility, applicability, tolerability, and preliminary response of a customised 3D-printed, thermoformed intraoral device for gingival topical treatment. Immune-mediated conditions, including oral lichen planus, mucous membrane pemphigoid, and pemphigus vulgaris often cause desquamative gingivitis. Topical corticosteroids are often ineffective in the oral environment, and frequent reapplication may increase systemic absorption. Methods: Two adults with immune-mediated gingival disease—oral lichen planus and mucous membrane pemphigoid—were unresponsive to topical corticosteroids. Following intraoral scanning, digital design, 3D printing, and thermoforming, each received a custom device with reservoirs over the lesions. They applied the corticosteroid gel and wore the device for 30 minutes, three times daily, in four cycles of five treatment days and two rest days. Results: Both cases completed the digital workflow successfully, with high compliance and no device-related mucosal irritation or pressure lesions. Mean pain scores fell from 8.5 at T0 to 4 at T1 (day 20) and 1.5 at T2 (day 40). Erythema and erosive areas decreased markedly, while symptoms nearly resolved. Conclusions: Device-mediated clobetasol was feasible, well tolerated, and effective in two topical treatment–resistant patients, but is currently limited to keratinized, dentition-supported sites (gingiva and palate). Randomized controlled trials must confirm efficacy versus conventional application.