Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial.
Pulp repair response after the use of a dentin-pulp biostimulation membrane (BBio) in primary teeth: study protocol for a randomized clinical trial.
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DOI：
10.1186/s13063-020-04785-2
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发表时间：
2020-10-22
期刊：
影响因子：
2.5
通讯作者：
Oliveira TM
中科院分区：
文献类型：
--
作者：
Machado MAAM;Stafuzza TC;Vitor LLR;da Costa SA;da Costa SM;Neto NL;Oliveira TM
活髓治疗的目的是维持受损但仍有活力的牙髓组织。因此，使用诱导组织再生的封盖材料是当前的大趋势。本研究的目的是从临床和影像学角度评价乳牙应用牙本质牙髓生物刺激膜后牙髓的修复情况。将选择来自5至9岁儿童的468颗牙齿，性别均不限，深龋病变累及牙髓，但无根分叉损伤和任何坏死迹象。活髓治疗采用三氧化矿物质聚合体（对照组）和牙本质牙髓生物刺激壳聚糖膜（BBio组）。将在治疗后12个月和24个月评估临床和影像学结局。将通过Image J2软件验证牙本质屏障的厚度。Wilcoxon符号秩检验和Mann-Whitney检验将分别比较组内和组间临床和影像学结局。配对t检验和独立t检验将分别比较组内和组间放射学测量值。将应用逻辑回归，并使用比值比（OR）和95%置信区间（95% CI）测量这种关联的程度。因此，本研究方案旨在通过采用新的易处理、低成本的材料来保持能够再生的牙髓组织的活力并维持乳牙脱落的生理过程，从而实现乳牙活髓治疗的新视角。巴西临床试验注册中心RBR-6vr 58 b。于2019年2月17日注册。
Vital pulp therapy aims at maintaining the pulp tissue injured but vital. Thus, the use of capping materials that induce tissue regeneration is a great current trend. This study aims to evaluate clinically and radiographically the pulp repair after the use of dentin-pulp biostimulation membrane in primary teeth. Four hundred and sixty-eight teeth from children aged between 5 and 9 years old, both genders, with deep caries lesion with pulp involvement, but no furcal impairment and any sign of necrosis will be selected. The vital pulp therapy will be performed with mineral trioxide aggregate (control group) and dentin-pulp biostimulation chitosan membrane (BBio group). The clinical and radiographic outcomes will be assessed at 12 and 24 months after treatment. The thickness of the dentin barrier will be verified through Image J2 software. The Wilcoxon signed rank test and Mann-Whitney test will respectively compare the intra- and intergroup clinical and radiographic outcomes. Paired t test and independent t test will respectively compare the intra- and intergroup radiographic measurements. The logistic regression will be applied, and the degrees of this association will be measured using odds ratio (OR) and 95% confidence interval (95% CI). Therefore, this study protocol aims at new perspectives of vital pulp therapy of primary teeth by employing new easy-handling, low-cost material to keep viable the pulp tissue capable of regenerating and maintain the physiological process of deciduous tooth exfoliation. Brazilian Registry of Clinical Trials RBR-6vr58b. Registered on 17 February 2019.
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影响因子：
6
作者：
Croisier, Florence;Jerome, Christine
通讯作者：
Jerome, Christine
影响因子：
2.2
作者：
Juneja, P.;Kulkarni, S.
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Kulkarni, S.
影响因子：
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作者：
Celik, Burcu Nihan;Mutluay, Merve Safa;Sari, Saziye
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影响因子：
1.3
作者：
Kalyan, K. S. D. Ravi;Vinay, C.;RojaRamya, K. S.
通讯作者：
RojaRamya, K. S.
影响因子：
2.2
作者：
Oliveira, T. M.;Moretti, A. B. S.;Abdo, R. C. C.
通讯作者：
Abdo, R. C. C.