The aim of this study was to evaluate the effectiveness of surgical excision to prevent cancer in patients with non-dysplastic oral leukoplakia (OL). This study was the first randomized controlled clinical trial comparing surgical treatment with standard care in this group of patients. Patients were divided into two groups. The first group underwent standard care, i.e. smoking counseling, follow-up visits every six months, and control biopsy when indicated. The second group underwent surgical excision, together with standard care. Oral cancer onset was the primary outcome; secondary outcomes included healing, recurrence after surgery, onset of new lesions, and worsening of the primary lesions. The differences in distribution of the patients' and lesions' characteristics were investigated through non-parametrical tests (Wilcoxon Rank-Sum and Fisher's Exact). Univariate and multivariate logistic regressions have been performed in order to estimate the Odds Ratio of the treatment on the recurrence or worsening of the lesions. A total of 260 patients took part in the study of which 132 were women (50.8%); during the follow-up period, two subjects developed oral cancer, one for each arm. Surgical treatment, when compared with standard care, was associated with a lower probability of the treated zone to remain healed during the follow up period (OR = 7.43; 95% CI=2.96-22.66). In conclusion, it is possible to assumed that regular clinical follow-up could be considered a reliable standard of care among patients with non-dysplastic OLs.

中文翻译：

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一项关于手术切除非发育不良性白斑预防口腔癌疗效的随机对照试验。

本研究的目的是评估手术切除对预防非发育不良口腔白斑（OL）患者癌症的有效性。这项研究是第一个在这组患者中比较手术治疗与标准治疗的随机对照临床试验。患者分为两组。第一组接受标准护理，即吸烟咨询、每六个月随访一次，并在需要时进行对照活检。第二组接受了手术切除和标准护理。口腔癌发病是主要结果；次要结局包括愈合、手术后复发、新病变的出现和原发病变的恶化。患者分布和病灶分布差异 通过非参数检验（Wilcoxon Rank-Sum 和 Fisher's Exact）研究特征。已经进行了单变量和多变量逻辑回归，以估计治疗对病变复发或恶化的优势比。共有 260 名患者参加了研究，其中 132 名是女性（50.8%）；在随访期间，两名受试者患上了口腔癌，每组一名。与标准治疗相比，手术治疗与治疗区域在随访期间保持愈合的可能性较低相关（OR = 7.43；95% CI = 2.96-22.66）。总之，可以假设定期临床随访可被认为是非发育不良 OL 患者的可靠护理标准。已经进行了单变量和多变量逻辑回归，以估计治疗对病变复发或恶化的优势比。共有 260 名患者参加了研究，其中 132 名是女性（50.8%）；在随访期间，两名受试者患上了口腔癌，每组一名。与标准治疗相比，手术治疗与治疗区域在随访期间保持愈合的可能性较低相关（OR = 7.43；95% CI = 2.96-22.66）。总之，可以假设定期临床随访可被认为是非发育不良 OL 患者的可靠护理标准。已经进行了单变量和多变量逻辑回归，以估计治疗对病变复发或恶化的优势比。共有 260 名患者参加了研究，其中 132 名是女性（50.8%）；在随访期间，两名受试者患上了口腔癌，每组一名。与标准治疗相比，手术治疗与治疗区域在随访期间保持愈合的可能性较低相关（OR = 7.43；95% CI = 2.96-22.66）。总之，可以假设定期临床随访可被认为是非发育不良 OL 患者的可靠护理标准。共有 260 名患者参加了研究，其中 132 名是女性（50.8%）；在随访期间，两名受试者患上了口腔癌，每组一名。与标准治疗相比，手术治疗与治疗区域在随访期间保持愈合的可能性较低相关（OR = 7.43；95% CI = 2.96-22.66）。总之，可以假设定期临床随访可被认为是非发育不良 OL 患者的可靠护理标准。共有 260 名患者参加了研究，其中 132 名是女性（50.8%）；在随访期间，两名受试者患上了口腔癌，每组一名。与标准治疗相比，手术治疗与治疗区域在随访期间保持愈合的可能性较低相关（OR = 7.43；95% CI = 2.96-22.66）。总之，可以假设定期临床随访可被认为是非发育不良 OL 患者的可靠护理标准。