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.
Szmirnov et al. (Tue,) studied this question.