Application of different biomaterials in the preservation of vital pulp in carious deciduous teeth: a prospective, single-center, randomized, controlled clinical trial / 中国组织工程研究

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 agentsMTA 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 identifierNCT03220360,on July 14,2017.The study protocol has been approved by the Ethics Committee of Chengdu Maternal and Child Center,China (approval number20170506).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.