Comparative Clinical and Radiographic Success Rate of Bioceramic Premix vs Biosilicate-based Medicament as Indirect Pulp Treatment Materials in Primary Molars: A Double-blind Randomized Trial with a Follow-up of 12 Months.

Payal Kothari, Aditi Mathur, Sunnypriyatham Tirupathi, Rashmi Chauhan, Meenakshi Nankar, Ashrita Suvarna
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Abstract

Aim: To evaluate and compare the clinical and radiographic success of NeoPUTTY® and Biodentine™ as indirect pulp treatment (IPT) materials in primary molars.

Materials and methods: This clinical trial was conducted on children aged 5-9 years. Class I carious lesions in primary molars indicated for IPT were divided into two groups-group I, NeoPUTTY®, and group II, Biodentine™. IPC was performed as per the standard protocols. The treated teeth were evaluated for clinical and radiographic success, along with the presence of a dentinal bridge at 6 and 12 months, by three blind examiners independently. All the data were tabulated, and statistical analysis was performed using the Mann-Whitney U test.

Results: Interexaminer reliability was analyzed using Fleiss κ statistics, and it showed "good" agreement. Clinical success was 100% in both groups at 6- and 12-month follow-up, while radiographic success was also 100% at 6-month follow-up for both groups. However, at 12-month follow-up, it was 93.33% for group I and 100% for group II. The difference was statistically nonsignificant. The presence of a dentinal bridge at 12-month follow-up was seen in 86.66% of cases in group I and 100% of cases in group II, but there was no statistical difference observed between them with a p-value of 0.555.

Conclusion: Within the limitations of the study, we conclude that NeoPUTTY® and Biodentine™ are equally effective as IPT agents in primary teeth.

How to cite this article: Kothari P, Mathur A, Tirupathi S, et al. Comparative Clinical and Radiographic Success Rate of Bioceramic Premix vs Biosilicate-based Medicament as Indirect Pulp Treatment Materials in Primary Molars: A Double-blind Randomized Trial with a Follow-up of 12 Months. Int J Clin Pediatr Dent 2024;17(7):748-753.

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生物陶瓷预混剂与生物硅酸盐类药物作为初级磨牙间接牙髓治疗材料的临床和放射学成功率比较:随访 12 个月的双盲随机试验。
目的:评估并比较 NeoPUTTY® 和 Biodentine™ 作为初级磨牙间接牙髓治疗(IPT)材料的临床和放射学效果:这项临床试验的对象是 5-9 岁的儿童。将需要进行间接牙髓治疗的初级磨牙 I 类龋病分为两组--I 组使用 NeoPUTTY®,II 组使用 Biodentine™。IPC按照标准方案进行。在 6 个月和 12 个月时,由三名盲人检查员独立评估治疗牙齿的临床和放射学成功率,以及牙桥的存在情况。所有数据均以表格形式列出,并采用曼-惠特尼 U 检验法进行统计分析:结果:使用 Fleiss κ 统计分析了检查者之间的可靠性,结果显示一致性 "良好"。在 6 个月和 12 个月的随访中,两组的临床成功率均为 100%,而在 6 个月的随访中,两组的放射学成功率也均为 100%。但在 12 个月的随访中,第一组的成功率为 93.33%,第二组为 100%。这一差异在统计学上并不显著。在 12 个月的随访中,86.66% 的第一组病例和 100%的第二组病例出现了牙桥,但两者之间没有统计学差异,P 值为 0.555:结论:在研究的限制条件下,我们得出结论:NeoPUTTY® 和 Biodentine™ 作为 IPT 药剂对乳牙同样有效:Kothari P, Mathur A, Tirupathi S, et al. 生物陶瓷预混剂与生物硅酸盐类药物作为初级磨牙间接牙髓治疗材料的临床和放射学成功率比较:随访 12 个月的双盲随机试验。Int J Clin Pediatr Dent 2024;17(7):748-753.
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