Clinical Outcomes Associated with a Propolis-Based Nano-Formulated Bioadhesive Oral Gel: A Retrospective Case Series and Non-Randomized Controlled Study in Patients with Intellectual Disabilities.

A propolis-based nano-formulated bioadhesive oral gel (NBF gel) containing vitamins C and E has been proposed as a supportive topical therapy for oral mucosal lesions. The aim of this study was to evaluate clinical outcomes associated with the use of the gel during a 15-year institutional clinical experience and to assess its adjunctive effect on periodontal status in patients with intellectual disabilities. The study consisted of two components: a retrospective observational case series and a non-randomized controlled clinical study. In the retrospective component, 295 patients (219 females and 76 males) received topical NBF gel treatment for various oral mucosal conditions, including xerostomia-associated mucositis, inflammatory lesions, aphthous ulcers, herpes infections, glossodynia, leukoplakia, erythroplakia, and post-surgical conditions. Treatment response was assessed descriptively using patient-reported symptom improvement combined with clinical evaluation. Overall, treatment was considered successful in 265/295 patients (89.8%), while 14/295 patients (4.7%) were classified as ineffective and 16/295 patients (5.4%) as inconclusive. More favorable responses were observed in inflammatory and post-treatment lesions than in potentially premalignant or neuropathic conditions. In the controlled periodontal component, 40 patients with mild to moderate intellectual disabilities were allocated into a control group performing toothbrushing alone and a test group additionally receiving topical NBF gel application. Periodontal status was assessed using the Basic Periodontal Examination (BPE) index at baseline and after 1 and 2 weeks. Adjunctive gel application was associated with greater improvement in periodontal status compared with toothbrushing alone. No clinically relevant adverse effects were documented during the observation period; however, because adverse events were not assessed using a predefined safety-monitoring protocol, these findings should be interpreted cautiously. The present findings suggest that the investigated nano-formulated bioadhesive oral gel may represent a potentially useful adjunctive topical therapy in selected oral mucosal and periodontal conditions. Further randomized controlled studies with standardized objective outcome measures are required to confirm these preliminary findings.