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评估含蜂胶加黑种草纳米颗粒的纳米乳剂用于乳牙活髓切断术的细胞毒性和疗效:随机双盲临床试验初步研究。

Evaluating the cytotoxicity and efficacy of nanoemulsion containing propolis plus Nigella sativa nanoparticles for pulpotomy of primary teeth: randomised split-mouth clinical trial pilot study.

作者信息

Osanloo A-M, Hamze F, Haghgoo R, Mashhadi-Abbas F, Papi F

机构信息

Private Practice, Tehran, Iran.

Operative Department, School of Dentistry, Shahed University, No. 71, Italia St., Vessal Ave., Keshavarz Blvd., Tehran, 1417755351, Iran.

出版信息

Eur Arch Paediatr Dent. 2025 Sep 13. doi: 10.1007/s40368-025-01091-w.

DOI:10.1007/s40368-025-01091-w
PMID:40944842
Abstract

PURPOSE

Due to strong suggestions about natural compounds, we evaluated the cytotoxicity of propolis and Nigella sativa nanoemulsion (NEPNS) and its effect for direct pulp capping of primary teeth.

METHODS

After preparing the NEPS extract, the MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) cytotoxicity test was performed. Then amongst children referred to the paediatric department, those whose healthy canines had to be extracted for orthodontic reasons were chose. Subsequent to pulpotomy of both canines, NEPNS were placed on one side and calcium-enriched mixture (CEM) on the other as pulp capping. Finally, after 30 days, the teeth were extracted and a blind pathologist examined the histopathology sections of the samples. Statistical analysis was performed using one-way ANOVA, Tukey post hoc, and Fisher exact test (α = 0.05).

RESULTS

Cytotoxicity test showed that cell viability exposed to 25 and 50 ppm of NEPNS were similar to the control group in 24 and 48 h. The histopathology showed that there was no significant difference between two groups in dentin bridge formation, pre-dentin production, foreign body reaction, and presence of dentin chips (P = 0.0242, 0.567, 0.098, and 0.999 respectively). Meanwhile, the inflammation was significantly lower (P = 0.0313) and odontoblastic differentiation was significantly higher in the CEM group (P = 0.015).

CONCLUSION

Incorporating NEPNS for direct pulp capping of primary teeth leads to mild inflammation comparing to CEM, but dentine bridge formation and developing pre-dentin was similar to the control group after 30 days.

TRIAL REGISTRATION

This prospective study was registered at the national clinical trials registry virtual platform as IRCT20230312057689N1 on 2 April 2023.

摘要

目的

鉴于对天然化合物的强烈建议,我们评估了蜂胶和黑种草纳米乳剂(NEPNS)的细胞毒性及其对乳牙直接盖髓的效果。

方法

制备NEPNS提取物后,进行MTT(3-(4,5-二甲基噻唑-2-基)-2,5-二苯基四氮唑溴盐)细胞毒性试验。然后,在转诊至儿科的儿童中,选择那些因正畸原因必须拔除健康犬齿的儿童。对两颗犬齿进行牙髓切断术后,一侧放置NEPNS,另一侧放置富钙混合物(CEM)作为盖髓材料。最后,30天后拔除牙齿,由一位盲法病理学家检查样本的组织病理学切片。采用单向方差分析、Tukey事后检验和Fisher精确检验进行统计分析(α = 0.05)。

结果

细胞毒性试验表明,在24小时和48小时时,暴露于25 ppm和50 ppm NEPNS的细胞活力与对照组相似。组织病理学显示,两组在牙本质桥形成、前期牙本质生成、异物反应和牙本质碎屑存在方面无显著差异(P分别为0.0242、0.567、0.098和0.999)。同时,CEM组的炎症明显更低(P = 0.0313),成牙本质细胞分化明显更高(P = 0.015)。

结论

与CEM相比,将NEPNS用于乳牙直接盖髓会导致炎症较轻,但30天后牙本质桥形成和前期牙本质发育与对照组相似。

试验注册

这项前瞻性研究于2023年4月2日在国家临床试验注册虚拟平台上注册,注册号为IRCT20230312057689N1。

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