One-year evaluation of a new restorative glass ionomer cement for the restoration of non-carious cervical lesions in patients with systemic diseases: a randomized, clinical trial

Abstract Objective This randomized and clinical trial aimed to evaluate the performance of a new restorative Glass Ionomer Cement (GIC) for the restoration of non-carious cervical lesions (NCCLs) of patients with systemic diseases compared with a posterior resin composite after 12 months. Methodology 134 restorations were placed at 30 patients presenting systemic diseases by a single clinician. NCCLs were allocated to two groups according to restorative system used: a conventional restorative GIC [Fuji Bulk (GC, Tokyo Japan) (FB)] and a posterior resin composite [G-ænial Posterior (GC, Tokyo Japan) (GP)] used with a universal adhesive using etch&rinse mode. All restorative procedures were conducted according to manufacturer’s instructions. Restorations were scored regarding retention, marginal discoloration, marginal adaptation, secondary caries, surface texture, and post-operative sensitivity using modified United States Public Health Service (USPHS) criteria after 1 week (baseline), 6, and 12 months. Descriptive statistics were performed using chi-square tests. Cochran Q and Mc Nemar’s tests were used to detect differences over time. Results After 12 months, recall rate was 93% and the rates of cumulative retention failure for FB and GP were 4.9% and 1.6% respectively. Both groups presented similar alpha rates for marginal adaptation (FB 86.2%, GP 95.5%) and marginal discoloration (FB 93.8%, GP 97%) at 6-month recall, but FB restorations showed higher bravo scores than GP restorations for marginal adaptation and marginal discoloration after 12 months (p<0.05). Regarding surface texture, 2 FB restorations (3.1%) were scored as bravo after 6 months. All restorations were scored as alpha for secondary caries and postoperative sensitivity after 12 months. Conclusion Although the posterior resin composite demonstrated clinically higher alpha scores than the conventional GIC for marginal adaptation and discoloration, both materials successfully restored NCCLs at patients with systematic disease after a year. Clinical relevance Due to its acceptable clinical results, the tested conventional restorative GIC can be used for the restoration of NCCLs of patients with systemic diseases.

摘要
目的
本随机临床试验旨在评估一款新型修复型玻璃离子水门汀（Glass Ionomer Cement, GIC）用于系统性疾病患者非龋性牙颈部缺损（non-carious cervical lesions, NCCLs）修复的临床效果，并与后牙复合树脂进行12个月的随访对比。
方法
由同一名临床医师为30名系统性疾病患者完成共134颗修复体。根据所使用的修复系统将NCCLs分为两组：传统修复型玻璃离子水门汀组[富士大块修复材料（Fuji Bulk, GC公司，日本东京，简称FB）]，以及采用酸蚀-冲洗模式通用粘接剂的后牙复合树脂组[G-ænial Posterior（GC公司，日本东京，简称GP）]。所有修复操作均严格遵循厂商说明书执行。分别于术后1周（基线）、6个月及12个月时，采用改良美国公共卫生服务（United States Public Health Service, USPHS）评分标准，对修复体的固位能力、边缘着色、边缘密合性、继发龋、表面纹理及术后敏感情况进行评估评分。采用卡方检验进行描述性统计，使用Cochran Q检验及McNemar检验分析随时间推移的组间差异。
结果
术后12个月时随访率为93%，FB组与GP组的累积固位失败率分别为4.9%与1.6%。术后6个月随访时，两组在边缘密合性（FB组86.2%，GP组95.5%）及边缘着色（FB组93.8%，GP组97%）方面的α级评分占比相近；但术后12个月时，FB组在边缘密合性与边缘着色两项指标上的Bravo评分显著高于GP组（p<0.05）。关于表面纹理指标，术后6个月时有2颗FB组修复体（3.1%）被评为Bravo级。术后12个月时，所有修复体在继发龋及术后敏感两项指标上均被评为α级。
结论
尽管术后12个月随访结果显示，后牙复合树脂在边缘密合性与边缘着色两项指标上的α级临床评分优于传统修复型玻璃离子水门汀，但两种材料均能为系统性疾病患者的非龋性牙颈部缺损提供为期1年的成功修复。
临床相关性
鉴于其可接受的临床疗效，本次试验所测试的传统修复型玻璃离子水门汀可用于系统性疾病患者的非龋性牙颈部缺损修复。