Dental Core Trainee, School of Dental Sciences, Faculty of Medical Sciences, Newcastle University and Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.
Trust Grade Dental Practitioner, School of Dental Sciences, Faculty of Medical Sciences, Newcastle University and Newcastle upon Tyne Hospital NHS Foundation Trust, Newcastle upon Tyne, UK.
Evid Based Dent. 2021 Dec;22(4):132-133. doi: 10.1038/s41432-021-0218-7. Epub 2021 Dec 16.
Design A two-arm parallel group, tooth-randomised, controlled, non-inferiority clinical trial.Case selection Participants were cooperative 3-9-year-old children of good health, presenting with at least one International Caries Detection and Assessment System (ICDAS) Grade 5 cavitated dentine occlusal carious lesion, with radiographic depth into dentine. Teeth included were symptom-free, non-mobile and had no more than one-third root resorption.Participants were treated and followed-up at The Paediatric Dental Clinic of the Federal University of Rio Grande do Sul, School of Dentistry, Porto Alegre, Brazil. Ethics approval was granted by the Research Ethics Committee of University of Rio Grande do Sul, Brazil.Data analysis In total, 93 children (n = 698 teeth) were evaluated. Clinical examination was performed by two operators, trained and calibrated for caries assessment, for lesion presence and depth. Kappa statistics were used to determine inter-examiner reliability. All participants received standardised toothbrushing instructions, dietary advice and dental prophylaxis before their intervention.Teeth were randomly allocated into one of the two intervention groups using a random number generator. The 'sealing group' had their occlusal lesions sealed with resin-modified glass ionomer cements (RMGIC), without any caries removal, according to manufacturer's instruction. The 'restoration group' had selective caries removal performed with a round, steel bur according to the clinical hardness criteria and were then restored with the same RMGIC as the 'sealing group', again according to manufacturer's instruction. The treatments were performed by two experienced paediatric dental specialists. No local anaesthetic was needed in either group.Patients were followed-up at 6, 12, 18 and 24 months after treatment for examination, prophylaxis and interproximal radiography. Any asymptomatic teeth with marginal deterioration which could be probed underwent reintervention and were maintained in the sample.Cavity volume in the 'restoration group' was statistically significantly greater (p = 0.01) than the 'sealing group'. All other baseline sample characteristics were not significantly different.Results Overall, 68 teeth were included at the start of the study; n = 31 in the 'sealing group' and n = 37 in the 'restoration group'. At one-year post-intervention, 60 teeth were examined. Overall success rate was 59.3% for the 'sealing group' and 78.8% for the 'restoration group'. At two-years post-intervention, 48 teeth were examined. Overall success rate was 48.8% in the 'sealing group' and 76.0% in the 'restoration group'. Over the follow-up period, no radiographic lesion progression was observed in either group.Conclusions Sealing ICDAS Grade 5 occlusal caries with RMGIC without any caries removal resulted in lower survival rates at two-years compared to the same material following selective caries removal.
一项采用双臂平行分组、牙随机、对照、非劣效性临床试验。
参与者为合作的 3-9 岁健康儿童，至少有一颗 ICDAS 等级 5 窝沟龋损，有牙本质龋坏，影像学深度达牙本质。纳入的牙齿无症状、无松动，根吸收不超过三分之一。参与者在巴西阿雷格里港联邦大学牙科学院儿科牙科诊所接受治疗和随访。巴西里奥格兰德联邦大学的研究伦理委员会批准了该研究的伦理。
共有 93 名儿童（n=698 颗牙）参与了评估。临床检查由两名经过培训和校准的龋病评估技师进行，以确定病变的存在和深度。Kappa 统计用于确定检查者之间的可靠性。所有参与者在干预前均接受标准化的刷牙指导、饮食建议和口腔预防保健。
牙齿采用随机数发生器随机分配到两个干预组之一。“密封组”根据制造商的说明，用树脂改性玻璃离子水门汀（RMGIC）密封其窝沟龋损，无需任何去龋。“修复组”根据临床硬度标准进行选择性去龋，然后用与“密封组”相同的 RMGIC 修复，也按照制造商的说明进行。治疗由两名经验丰富的儿科牙科专家进行。两组均无需使用局部麻醉。
治疗后 6、12、18 和 24 个月，患者进行检查、预防和邻面放射检查。任何无症状、边缘恶化且可探测到的牙齿均进行再干预，并保留在样本中。“修复组”的窝洞体积明显大于“密封组”（p=0.01）。所有其他基线样本特征均无显著差异。
总体而言，研究开始时有 68 颗牙纳入；“密封组”n=31，“修复组”n=37。干预后 1 年，共检查 60 颗牙。“密封组”的总体成功率为 59.3%，“修复组”的成功率为 78.8%。干预后 2 年，共检查 48 颗牙。“密封组”的总体成功率为 48.8%，“修复组”的成功率为 76.0%。在随访期间，两组均未观察到放射学病变进展。
用 RMGIC 密封 ICDAS 等级 5 窝沟龋，不进行任何去龋处理，与选择性去龋后使用相同材料相比，两年后的生存率较低。
