Preclinical Evaluation and Clinical Trial of Chlorhexidine Polymer Scaffold for Vital Pulp Therapy
Preclinical Evaluation and Clinical Trial of Chlorhexidine Polymer Scaffold for Vital Pulp Therapy
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DOI：
10.17796/1053-4625-43.2.7
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发表时间：
2019-01-01
影响因子：
1.3
通讯作者：
RojaRamya, K. S.
中科院分区：
文献类型：
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作者：
Kalyan, K. S. D. Ravi;Vinay, C.;RojaRamya, K. S.
目的：评价洗必泰聚合物支架在活髓治疗中的临床前有效性和临床疗效。研究设计：通过静电纺丝制备负载洗必泰的聚合物支架。使用四种不同的测试来评估支架：i）通过傅立叶变换红外光谱（FTIR）评估氯己定从聚合物支架的释放; ii）通过皮下植入兔来测试氯己定支架的生物相容性; iii）将支架植入人磨牙中以进行进一步的离体组织学评估;和iv）在34名6至8岁儿童的40颗乳磨牙的临床试验中，与MTA（对照）相比，评价支架作为活髓治疗后的牙髓敷料的临床功效。结果：该支架对变形链球菌、乳酸杆菌等兼性厌氧菌有一定的抗菌作用。傅立叶变换红外光谱证实了支架中存在洗必泰和聚乙烯醇。兔皮下组织和离体人磨牙的组织学评价提供了对支架的可接受的生物相容性反应。临床试验表明，负载洗必泰的支架的有效率为90%，与MTA相当。结论：支架在进行的所有四项试验（包括临床试验）中均符合可接受的标准。在成年牙齿中使用氯己定支架进行更大规模的临床试验可能需要证明其有效性。初步临床试验结果表明，支架有利于保存需要活髓切断术治疗的乳牙。
Objective: To evaluate the preclinical effectiveness and clinical efficacy of chlorhexidine polymer scaffold for vital pulp therapy. Study design: Polymer scaffolds loaded with chlorhexidine were prepared by electrospinning. The scaffolds were evaluated using four different tests: i) The release of chlorhexidine from the polymer scaffold was evaluated by Fourier-transform infrared spectroscopy (FTIR); ii) Biocompatibility of chlorhexidine scaffold was tested by subcutaneous implantation in rabbits; iii) The scaffolds were implanted into human molars for further ex vivo histological evaluation; and iv) The clinical efficacy of the scaffold was evaluated as a pulp dressing following vital pulp therapy, in comparison with MTA (control) in a clinical trial of forty primary molar teeth in 34 children aged 6 to 8 years. Results: The scaffold was antimicrobial to Streptococcus mutans, Lactobacilli and other facultative anaerobes. Fourier-transform infrared spectroscopy confirmed the presence of chlorhexidine and polyvinyl alcohol in the scaffold. The histological evaluation of the subcutaneous tissue of rabbits and ex vivo human molars provided an acceptable biocompatibility response to scaffold. The clinical trial showed that the efficacy of chlorhexidine loaded scaffold was 90% and comparable to MTA. Conclusion: The scaffold met acceptable standards in all the four tests that were performed, including the clinical trial. A larger clinical trial with chlorhexidine scaffold in adult teeth may be necessary to prove its efficacy. The preliminary clinical trial results demonstrated that the scaffold was beneficial in saving primary teeth that required pulpotomy as a vital pulp therapy.