Endodontology Research Center, Kerman University of Medical Sciences, Kerman, Iran.
Social Determinants on Oral Health Research Center, Kerman University of Medical Sciences, Kerman, Iran.
BMC Oral Health. 2024 Aug 14;24(1):943. doi: 10.1186/s12903-024-04449-6.
Self-adhering flowable composites are an innovative step in reducing the chair time of pit and fissure sealant treatment. This study aimed to compare the clinical performance of self-adhering flowable composite (SELF-ADH) and resin-based pit and fissure sealant (RBs).
This is a double-blinded, randomized, split-mouth clinical trial conducted on 80 fully erupted permanent mandibular first molars from 40 children aged 6 to 12 years. For each participant, two permanent molars were randomly treated with SELF-ADH or RB. All sealants were assessed at 3, 6, and 12-month follow-ups considering retention, marginal integrity, marginal discolouration, colour matching, surface texture, and caries recurrence. To analyse the data, logistic regression and Fisher's exact tests were used (significance level P < 0.05).
At the 12-month follow-up, the number of fully retained sealants in the SELF-ADH group was significantly higher than that in the RB group (P < 0.001). Also, The success rate of marginal integrity in the SELF-ADH group was significantly greater than the the RB group (P = 0.031), while the rate of sealant marginal discolouration was higher in the RB group (P < 0.001). The incidence of recurrent caries in teeth with partial loss of sealant in both groups (P = 0.004, P < 0.001) increased significantly over time.
The retention and marginal integrity of the self-adhering flowable composite were significantly greater than those of the resin-based sealant. Therefore, due to the small number of work steps, flowable self-adhering composites can be used as alternatives to resin-based pit and fissure sealants.
This study was approved by the Ethics Committee of Kerman University of Medical Sciences with the code IR.KMU.REC.1399.556 and Iraninan Registry of Clinical Trials (IRCT) code IRCT20180521039763N4, as well as full compliance with the Declaration of Helsinki.
自黏流动复合树脂在减少窝沟封闭治疗椅时间方面是一个创新的步骤。本研究旨在比较自黏流动复合树脂（SELF-ADH）和树脂基窝沟封闭剂（RBs）的临床性能。
这是一项双盲、随机、分口临床试验，共纳入 40 名 6-12 岁儿童的 80 颗完全萌出的下颌第一恒磨牙。对于每个参与者，两颗恒磨牙随机用 SELF-ADH 或 RB 处理。所有封闭剂在 3、6 和 12 个月的随访中，根据保留情况、边缘完整性、边缘变色、颜色匹配、表面纹理和龋齿复发进行评估。为了分析数据，使用逻辑回归和 Fisher 确切检验（显著性水平 P<0.05）。
在 12 个月的随访中，SELF-ADH 组完全保留的封闭剂数量明显高于 RB 组（P<0.001）。此外，SELF-ADH 组边缘完整性的成功率明显大于 RB 组（P=0.031），而 RB 组的封闭剂边缘变色率较高（P<0.001）。两组中部分封闭剂丢失的牙齿的龋齿复发率随着时间的推移显著增加（P=0.004，P<0.001）。
自黏流动复合树脂的保留率和边缘完整性明显大于树脂基封闭剂。因此，由于操作步骤较少，流动自黏复合树脂可以替代树脂基窝沟封闭剂。
本研究得到了克尔曼医科大学伦理委员会的批准，注册号为 IR.KMU.REC.1399.556 和伊朗临床试验注册中心（IRCT）注册号 IRCT20180521039763N4，并且完全符合《赫尔辛基宣言》。
