Bianchi Renata M D, Pascareli-Carlos Aline M, Floriano Isabela, Raggio Daniela P, Braga Mariana M, Gimenez Thais, Holanda Mariana C, da Silva Gabriela S, de Natal Karina H, Tedesco Tamara K
Graduate Program in Dentistry, Ibirapuera University, Av. Interlagos 1329, São Paulo, SP, 04661-100, Brazil.
School of Dentistry, Universidade Do Norte, Uninorte, Av. Joaquim Nabuco, Centro, Manaus, 12811355, Brazil.
BMC Oral Health. 2021 Mar 31;21(1):167. doi: 10.1186/s12903-021-01524-0.
Studies have questioned the necessity of restoring cavitated carious lesion on primary teeth, once the control of biofilm is the most important factor to arrest these lesions. This randomized clinical trial aimed to compare the survival of teeth treated with a non-restorative cavity control (NRCC) compared to resin composite restorations (RCR) on proximal carious lesion in anterior primary teeth, as well as the impact of these treatments on patient-centered outcomes.
A randomized clinical trial with two parallels arms (1:1) will be conducted. Children between 3 and 6 years old will be selected from the Center of Clinic Research of Pediatric Dentistry of Ibirapuera University (UNIB), a dental trailer (FOUSP) located on Educational Complex Professor Carlos Osmarinho de Lima, the Pediatric Dentistry Clinic of Santa Cecília University and from the Pediatric Dentistry Clinic of University Center UNINOVAFAPI. One hundred and forty-eight teeth will be randomly distributed in two experimental groups: (1) Selective removal of carious tissue and RCR; or (2) NRCC through cavity enlargement using a metallic sandpaper. The primary outcome will be tooth survival after 6, 12, 18 and 24 months. The duration and the cost of dental treatments will be considered for the estimation of the cost-effectiveness of the evaluated treatments. The discomfort reported by the participants will be measured after each treatment using the FIS scale. The participants' satisfaction and perception of the parents/legal guardians will be evaluated through questionnaires. For the primary outcome, Kaplan-Meier's survival and Long-Rank test will be used for comparison between the two groups. All the variables will be modeled by Cox regression with shared fragility. Significance will be considered at 5%.
The NRCC could be an option to manage carious lesions on proximal surfaces of primary teeth, and the approach could be well accepted by the children and parents/legal guardians. Trial registration Clinicaltrials.gov registration: NCT03785730, Registered on December 18th 2018, first participant recruited 30/04/2019, https://clinicaltrials.gov/ct2/show/NCT03785730 . Ethics Reference No: 91569118.8.0000.5597. Trial Sponsor: Universidade Ibirapuera. The Trial was prospectively registered.
研究对乳牙龋洞病变修复的必要性提出了质疑，因为控制生物膜是阻止这些病变的最重要因素。这项随机临床试验旨在比较非修复性龋洞控制（NRCC）与树脂复合修复（RCR）治疗前牙邻面龋损乳牙的牙齿存活率，以及这些治疗对以患者为中心的结局的影响。
将进行一项双臂平行（1:1）的随机临床试验。3至6岁的儿童将从伊比拉普埃拉大学（UNIB）儿童牙科临床研究中心、位于卡洛斯·奥斯马里尼奥·德利马教授教育综合大楼的牙科拖车（FOUSP）、圣塞西莉亚大学儿童牙科诊所和大学中心UNINOVAFAPI儿童牙科诊所中选取。148颗牙齿将随机分配到两个实验组：（1）选择性去除龋坏组织并进行RCR；或（2）使用金属砂纸扩大龋洞进行NRCC。主要结局将是6、12、18和24个月后的牙齿存活率。在评估治疗的成本效益时，将考虑牙科治疗的持续时间和成本。使用FIS量表在每次治疗后测量参与者报告的不适程度。通过问卷评估参与者及其父母/法定监护人的满意度和看法。对于主要结局，将使用Kaplan-Meier生存曲线和长秩检验对两组进行比较。所有变量将通过具有共享脆弱性的Cox回归进行建模。显著性水平将设定为5%。
NRCC可能是处理乳牙邻面龋损的一种选择，并且这种方法可能会被儿童及其父母/法定监护人很好地接受。试验注册Clinicaltrials.gov注册编号：NCT03785730，于2018年12月18日注册，第一名参与者于2019年4月30日招募入组，https://clinicaltrials.gov/ct2/show/NCT03785730 。伦理参考编号：91569118.8.0000.5597。试验主办方：伊比拉普埃拉大学。该试验已进行前瞻性注册。
