Department of Oral Medicine, School of Dental Medicine, University of Zagreb, Zagreb, Croatia.
Department of Dentistry, Clinical Hospital Center Zagreb, Zagreb, Croatia.
PLoS One. 2021 Apr 8;16(4):e0249862. doi: 10.1371/journal.pone.0249862. eCollection 2021.
To evaluate the effectiveness of non-aromatic very rich in steranes (NAVS) naphthalan in the treatment of oral lichen planus (OLP) and recurrent aphthous stomatitis (RAS). Null hypothesis was that there would be no difference between NAVS and topical steroids in the treatment of OLP and RAS.
The study consisted of two sub-trials conducted as randomized, double-blind controlled studies: first included OLP patients and second patients with RAS. Patients received either NAVS or 0.05% betamethasone dipropionate. Primary outcomes were activity score (OLP patients), No of lesions and lesion diameter (RAS patients) and pain intensity (VAS) while secondary outcome included the impact of the disease on quality of life assessed by Oral health impact profile (OHIP 14).
No significant differences in terms of OLP clinical signs (p = 0.84, η2 = 0.001) and responses on the OHIP-14 (p = 0.81, η2 = 0.002) or on VAS (p = 0.14, η2 = 0.079) between NAVS and betamethasone groups were observed. In RAS patients, no significant differences between the groups in terms of lesion number (at days 3 and 5, p = 0.33 and p = 0.98, respectively), lesion diameter (days 3 and 5, p = 0.24 and p = 0.84, respectively) were observed. However, in NAVS group a significant reduction of lesions diameter was observed on the 3rd day, while in betamethasone group a significant reduction in lesions diameter was evident only after the 5th day. No significant differences in VAS (p > 0.05) and the OHIP-14 (p > 0.05) between groups were found.
No evidence of differences between the two compared interventions was found.
Retrospective registration of this trial was conducted in ClinicalTrials.gov on September 30, 2016; trial registration number: NCT02920658. https://clinicaltrials.gov/ct2/show/NCT02920658?term=NAVS&draw=2&rank=4.
评估富含非芳甾烷 NAVS 萘烷在治疗口腔扁平苔藓（OLP）和复发性阿弗他口炎（RAS）中的疗效。零假设是 NAVS 与局部皮质类固醇在治疗 OLP 和 RAS 方面没有差异。
该研究包括两项作为随机、双盲对照研究进行的子试验：第一项包括 OLP 患者，第二项包括 RAS 患者。患者接受 NAVS 或 0.05%倍他米松二丙酸酯治疗。主要结局是活动评分（OLP 患者）、病变数量和病变直径（RAS 患者）以及疼痛强度（VAS），次要结局包括通过口腔健康影响概况（OHIP 14）评估疾病对生活质量的影响。
在 OLP 临床体征方面（p = 0.84，η2 = 0.001）和 OHIP-14 应答方面（p = 0.81，η2 = 0.002）或 VAS 应答方面（p = 0.14，η2 = 0.079），NAVS 和倍他米松组之间均未观察到统计学差异。在 RAS 患者中，两组之间在病变数量方面（第 3 天和第 5 天，p = 0.33 和 p = 0.98）、病变直径方面（第 3 天和第 5 天，p = 0.24 和 p = 0.84）均无显著差异。然而，在 NAVS 组中，第 3 天观察到病变直径显著减小，而在倍他米松组中，仅在第 5 天观察到病变直径显著减小。两组之间的 VAS（p > 0.05）和 OHIP-14（p > 0.05）无显著差异。
未发现两种比较干预措施之间存在差异的证据。
该试验于 2016 年 9 月 30 日在 ClinicalTrials.gov 进行了回顾性注册；试验注册号：NCT02920658。https://clinicaltrials.gov/ct2/show/NCT02920658?term=NAVS&draw=2&rank=4.
