Application of different biomaterials in the preservation of vital pulp in carious deciduous teeth: a prospective, single-center, randomized, controlled clinical trial

doi:10.3969/j.issn.2095-4344.2017.22.009

Abstract

Abstract:

BACKGROUND: The success of the preservation of vital pulp in carious deciduous teeth depends not only on determining the health status of the pulp, but also on selecting the most suitable pulp capping agent. At present, the commonly used pulp capping agent materials contain calcium hydroxide preparation and mineral trioxide aggregate (MTA). Recently, new biomaterials, such as Bioaggregate, Biodentine, and TheraCal, with good biocompatibility and good edge sealing, have been developed and extensively used.

OBJECTIVE: To compare the efficacies of MTA, calcium hydroxide preparation, Biodentine and TheraCal LC that are commonly used in pediatric dentistry in the preservation of vital pulp in carious deciduous teeth.

METHODS: This prospective, single-center, randomized controlled clinical trial will be conducted in Chengdu Maternal and Child Center, China. Children with deep caries of deciduous teeth, who will be scheduled to undergo indirect pulp capping, direct pulp capping, and vital pulpotomy, will be selected and randomized into four groups according to pulp capping agents: MTA group, calcium hydroxide group, Biodentine group and TheraCal group. Patients will receive return visit at postoperative 3, 6 and 12 months during follow-up. By using X-ray, we will observe and compare the speed and quality of the formation of the dentin bridge with different biomaterials, and assess the reason for the failure of treatment. This trial was registered in ClinicalTrials.gov identifier: NCT03220360, on July 14, 2017. The study protocol has been approved by the Ethics Committee of Chengdu Maternal and Child Center, China (approval number: 20170506). All protocols will be performed in accordance with the Ethical Principles for Medical Research Involving Human Subjects in the Declaration of Helsinki. Written informed consent will be provided by each patient and their family members after they indicated that they fully understood the treatment plan.

RESULTS AND CONCLUSION: This study will compare the efficacies of various biomaterials in the preservation of vital pulp in carious deciduous teeth. New materials Biodentine and TheraCal will be selected in classical technique to verify their efficacies and explore their superiorities. Classical materials calcium hydroxide and MTA will be selected as controls, which will be separately used in indirect pulp capping, direct pulp capping, and vital pulpotomy to provide reliable choices for clinicians.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

Key words: Biocompatible Materials, Pulp Capping and Pulpectomy agents, Tooth, Deciduous, Dental Pulp Capping, Tissue Engineering

CLC Number:

R318

Ma Xiao-hong, Xie Ni-na.

Application of different biomaterials in the preservation of vital pulp in carious deciduous teeth: a prospective, single-center, randomized, controlled clinical trial

[J]. Chinese Journal of Tissue Engineering Research, 2017, 21(22): 3494-3500.

Figures/Tables 4

References

[1]赵玮,高硕.乳牙牙髓病及根尖周病的临床治疗原则及注意事项[J].中国实用口腔科杂志,2011,4(1):4-7．

[2]陈娥.儿童牙髓病和根尖周病治疗的原则及方法[J].现代临床医学，2007,33 (suppl,2):260-262.

[3]Parisay I, Ghoddusi J, Forghani M.A review on vital pulp therapy in primary teeth.Iran Endod J. 2015 Winter;10(1): 6-15.

[4]Akhlaghi N, Khademi A.Outcomes of vital pulp therapy in permanent teeth with different medicaments based on review of the literature.Dent Res J (Isfahan). 2015; 12(5):406-417.

[5]Fuks AB.Pulp therapy for the primary and young permanent dentitions.Dent Clin North Am. 2000;44(3):571-96, vii.

[6]Donmez SB, Turgut MD, Uysal S,et al.Randomized Clinical Trial of Composite Restorations in Primary Teeth: Effect of Adhesive System after Three Years.Biomed Res Int. 2016; 2016:5409392.

[7]Conti TR, Sakai VT, Fornetti AP, et al.Pulpotomies with Portland cement in human primary molars.J Appl Oral Sci. 2009;17(1):66-69.

[8]Smaïl-Faugeron V, Courson F, Durieux P, et al.Pulp treatment for extensive decay in primary teeth.Cochrane Database Syst Rev. 2014; (8):CD003220.

[9]Kindelan SA, Day P, Nichol R,et al.UK National Clinical Guidelines in Paediatric Dentistry: stainless steel preformed crowns for primary molars.Int J Paediatr Dent. 2008;18 Suppl 1:20-28.

[10]Smallridge J.UK National Clinical Guidelines in Paediatric Dentistry: Use of fissure sealants including management of the stained fissure in first permanent molars.Int J Paediatr Dent. 2010 Jun 2. doi: 10.1111/j.1365-263X.2009.01035.x.

[11]No authors listed.American Academy of Pediatric Dentistry reference manual 2009-2010.Pediatr Dent. 2009;31 (6 Reference Manual):1-302.

[12]Samprasit W, Rojanarata T, Akkaramongkolporn P, et al.Fabrication and In Vitro/In Vivo Performance of Mucoadhesive Electrospun Nanofiber Mats Containing α-Mangostin.AAPS PharmSciTech. 2015; 16(5):1140-1152.

[13]Shayegan A,Jurysta C,Atash R,et al. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent.2012; 34(7):e202-e208.

[14]Ree MH, Schwartz RS.Long-term Success of Nonvital, Immature Permanent Incisors Treated With a Mineral Trioxide Aggregate Plug and Adhesive Restorations: A Case Series from a Private Endodontic Practice.J Endod. 2017. pii: S0099-2399(17)30262-5.

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