Division of Public and Child Dental Health, School of Dental Science, Trinity College Dublin, Dublin, Ireland.
Department of Paediatric Dentistry, School of Dentistry, University of São Paulo, São Paulo, Brazil.
BMC Oral Health. 2022 Oct 10;22(1):440. doi: 10.1186/s12903-022-02449-y.
This non-inferiority randomised clinical trial aimed to evaluate the survival of direct bulk fill composite resin restorations in primary molars using different methods of moisture control: rubber dam isolation (RDI-local anaesthesia and rubber dam) and cotton roll isolation (CRI-cotton roll and saliva ejector). Secondary outcomes included baseline and 2-year incremental cost, self-reported child's pain scores and patient behaviour during the restorative procedure.
A total of 174 molars (93 children) with dentine caries lesions were randomly allocated to study groups (RDI or CRI) and restored with bulk fill composite resin by trained operators. Two blinded examiners assessed the restorations for up to 24 months. Wong-baker faces and Frankl's behaviour rating scales were used for accessing the child's pain and behaviour, respectively. The primary outcome (restoration survival) was analysed using the two-sample non-inferiority test for survival data using Cox Regression (non-inferiority/alternative hypothesis HR > 0.85; CI = 90%). Bootstrap Linear regression was used for cost analysis and logistic regression for pain and behaviour analysis (α = 5%).
After 2-years, 157 restorations were evaluated (drop-out = 9.7%). The survival rate was RDI = 60.4% and CRI = 54.3%. The non-inferiority hypothesis was accepted by the Cox Regression analysis (HR = 1.33; 90% CI 0.88-1.99; p = 0.036). RDI was 53% more expensive when compared to the CRI group. No differences were found between the groups regarding pain (p = 0.073) and behaviour (p = 0.788).
Cotton roll isolation proved to be non-inferior when compared to rubber dam for composite restorations longevity in primary molars. Furthermore, the latest presented the disadvantage of higher cost and longer procedure time. Clinical Significance The moisture control method does not influence the longevity of composite restorations in primary molars. Cotton roll isolation proved to be non-inferior to rubber dam isolation and is a viable option for restoring primary molars. Clinical trial registration registered NCT03733522 on 07/11/2018. The present trial was nested within another clinical trial, the CARies DEtection in Children (CARDEC-03-NCT03520309).
本非劣效性随机临床试验旨在评估在乳磨牙中使用不同的隔湿方法（橡皮障隔离[RDI-局部麻醉和橡皮障]和棉卷隔离[CRI-棉卷和唾液抽吸器]）对直接大块填充复合树脂修复体的生存情况。次要结局包括基线和 2 年增量成本、自我报告的儿童疼痛评分和修复过程中患者的行为。
共 174 颗磨牙（93 名儿童）有牙本质龋损，随机分为研究组（RDI 或 CRI），并由经过培训的操作人员用大块填充复合树脂修复。两名盲法检查者在长达 24 个月时评估修复体。Wong-baker 面部表情量表和 Frankl 行为评分量表分别用于评估儿童的疼痛和行为。主要结局（修复体生存情况）采用 Cox 回归的两样本非劣效性检验进行分析（非劣效性/替代假设 HR>0.85；CI=90%）。Bootstrap 线性回归用于成本分析，逻辑回归用于疼痛和行为分析（α=5%）。
2 年后，157 个修复体进行了评估（脱落率为 9.7%）。RDI 的生存率为 60.4%，CRI 为 54.3%。Cox 回归分析接受了非劣效性假设（HR=1.33；90%CI 0.88-1.99；p=0.036）。与 CRI 组相比，RDI 组的成本高出 53%。两组在疼痛（p=0.073）和行为（p=0.788）方面无差异。
与橡皮障隔离相比，棉卷隔离在乳磨牙复合树脂修复体的耐久性方面不劣于橡皮障隔离。此外，后者具有成本较高和操作时间较长的缺点。
隔湿方法并不影响乳磨牙复合树脂修复体的寿命。棉卷隔离与橡皮障隔离等效，是修复乳磨牙的一种可行选择。
NCT03733522，于 2018 年 11 月 7 日注册。本试验嵌套于另一项临床试验 CARies DEtection in Children（CARDEC-03-NCT03520309）中。
