Lodolo Michele, Thanasuwat Burinrutt, Veluppillai Piri, Bassani Gus, Villa Alessandro
Department of Orofacial Sciences, School of Dentistry, University of California San Francisco, San Francisco, California, USA.
Professional Compounding Centers of America, Houston, Texas, USA.
J Oral Pathol Med. 2023 Oct;52(9):860-866. doi: 10.1111/jop.13471. Epub 2023 Aug 7.
Mucolox™ is a mucosal drug delivery system that prolongs the contact time between the oral mucosa and topical corticosteroids, potentially reducing the need for multiple applications daily. This study aimed to assess the clinical efficacy and tolerability of dexamethasone 0.5 mg/5 mL solution in Mucolox™ for the management of oral inflammatory ulcerative diseases.
Participants were randomly assigned to receive dexamethasone 0.5 mg/5 mL in Mucolox™ (Mucolox™ arm) or dexamethasone 0.5 mg/5 mL solution (standard arm) and instructed to swish/gargle for 5 min three times daily. Changes from pre- to posttreatment patient's sensitivity score (0-10 on a visual analog scale), reticulation/erythema/ulceration score, and oral health-related quality of life were evaluated at baseline and at the end of the study period.
Twenty nine patients (75% females) with a median age of 58 years (range 18-79) were enrolled and randomly allocated to the Mucolox™ or standard arm. One subject was excluded. Although statistically significant in both arms, the pre- to posttreatment sensitivity score reduction was higher in the Mucolox™ arm (6.3 vs. 4.4-point reduction). Both arms showed a decrease in the reticulation/erythema/ulceration score between the two visits (7.2 vs. 4.7 [Mucolox™ arm]; 8.0 vs. 4.8 [standard arm]; p > 0.05). Mucolox™ in dexamethasone 0.5 mg/5 mL solution was better tolerated when taste and level of comfort were considered.
Both treatments were effective in the management of oral inflammatory ulcerative diseases. Dexamethasone 0.5 mg/5 mL in Mucolox™ was better tolerated and was slightly better in controlling patients' oral sensitivity. Larger studies are needed to confirm these findings in oral inflammatory ulcerative diseases patients.
ClinicalTrials.gov Identifier: NCT04540133.
Mucolox™是一种黏膜给药系统，可延长口腔黏膜与局部皮质类固醇之间的接触时间，可能减少每日多次用药的需求。本研究旨在评估Mucolox™中0.5毫克/5毫升地塞米松溶液治疗口腔炎性溃疡性疾病的临床疗效和耐受性。
参与者被随机分配接受Mucolox™中的0.5毫克/5毫升地塞米松（Mucolox™组）或0.5毫克/5毫升地塞米松溶液（标准组），并被指示每天三次漱口/含漱5分钟。在基线和研究期末评估治疗前后患者的敏感性评分（视觉模拟量表上0至10分）、网状/红斑/溃疡评分以及口腔健康相关生活质量的变化。
纳入了29名患者（75%为女性），中位年龄为58岁（范围18至79岁），并随机分配至Mucolox™组或标准组。一名受试者被排除。虽然两组均有统计学意义，但Mucolox™组治疗前后的敏感性评分降低幅度更高（降低6.3分对4.4分）。两次就诊之间，两组的网状/红斑/溃疡评分均有所下降（Mucolox™组为7.2对4.7；标准组为8.0对4.8；p>0.05）。考虑到味道和舒适度，0.5毫克/5毫升地塞米松溶液中的Mucolox™耐受性更好。
两种治疗方法对口腔炎性溃疡性疾病均有效。Mucolox™中的0.5毫克/5毫升地塞米松耐受性更好，在控制患者口腔敏感性方面略优。需要更大规模的研究来在口腔炎性溃疡性疾病患者中证实这些发现。
ClinicalTrials.gov标识符：NCT04540133。
