Nagar Niall
Glasgow Dental Hospital, Glasgow, UK.
Evid Based Dent. 2024 Sep;25(3):150-151. doi: 10.1038/s41432-024-01039-x. Epub 2024 Jul 30.
Double-blind (participant and outcome assessor), randomised, non-inferiority, two-arm (1:1 allocation) clinical trial.
The study included children aged 4-8 years old from public schools in Tietê, Brazil, who had mesio-occlusal carious lesions, into dentine, in primary molars. The carious teeth had to be asymptomatic of pulpal involvement. The children had to be medically fit and cooperative for dental treatment within their classroom environment. Consent was gained from a parent/guardian prior to entering the study. Children with carious lesions in multiple teeth, only one tooth was included, which was selected by a random draw. Treatment on other teeth would be carried out in the nearest health centre.
The primary outcome was the 2-year survival of the restorations, analysed using Kaplan-Meier survival curves and Cox regression (α = 5%). Costs for materials and professional services were recorded in Brazilian Reais (R$), converted to US dollars (US$), and analysed using Monte Carlo simulation.
Of the 152 children enrolled (76 per group), 121 (79%) were evaluated at the 2-year mark. Overall, the 2-year survival rate of the restorations was 39% (EF: 45%; RSC: 32%), with no significant difference between the two groups. The total cost of restorations with RSC was lower than with EF, resulting in a cost saving of US$6.18 per restoration.
After 2 years, Riva Self Cure demonstrated comparable survival rates to Equia Forte for mesio-occlusal restorations in primary molars, while being more cost-effective from a Brazilian perspective.
双盲(参与者和结果评估者)、随机、非劣效性、双臂(1:1分配)临床试验。
该研究纳入了来自巴西蒂埃特公立学校的4至8岁儿童,这些儿童的乳磨牙有近中咬合面龋损,已累及牙本质。龋坏牙齿必须无牙髓受累症状。儿童必须身体健康,并且能够在课堂环境中配合牙科治疗。在进入研究前获得了家长/监护人的同意。有多颗牙齿龋损的儿童,仅纳入一颗通过随机抽签选择的牙齿。其他牙齿的治疗将在最近的健康中心进行。
主要结局是修复体的2年生存率,使用Kaplan-Meier生存曲线和Cox回归进行分析(α = 5%)。材料和专业服务成本以巴西雷亚尔(R$)记录,换算为美元(US$),并使用蒙特卡洛模拟进行分析。
在纳入的152名儿童(每组76名)中,121名(79%)在2年时接受了评估。总体而言,修复体的2年生存率为39%(EF组:45%;RSC组:32%),两组之间无显著差异。RSC修复的总成本低于EF修复,每颗修复体节省成本6.18美元。
2年后,对于乳磨牙近中咬合面修复,Riva Self Cure的生存率与Equia Forte相当,而从巴西的角度来看,其成本效益更高。