Outcomes Of Indirect Pulp Capping By Using Either ProRoot Mineral Trioxide Aggregate Or Biodentine In The Reversible Pulpitis Caused By Caries Of Permanent Teeth: A Randomized Controlled Trial

Introduction:This clinical study aimed to compare the short-term efficacy of indirect pulp capping by using either ProRoot Mineral Trioxide Aggregate(MTA)or Biodentine in the reversible pulpitis of permanent teeth caused by caries,A non-inferiority randomized controlled trial.Methods:This study conducted patients who were treated at the Department of Endodontics of the Stomatological Hospital of Tianjin Medical University from October 2014 to October 2018.According to the diagnostic criteria of the American Association of Endodontists(AAE),75 cases of reversible pulpitis caused by deep caries were collected according to the inclusion criteria and exclusion criteria.Communicate fully with the patient before the operation and sign the informed consent form.According to the results of the Cold test(C)and Heat test(H)of pulp thermal test,all cases were first included in two layers,one layer was cold stimulation(+)and thermal stimulation(-),marked as C+H-;the other layer is cold stimulus(+)and thermal stimulus(+),marked as C+H+.Then,using a random number table method in each layer,according to the two different pulp capping agents used MTA or Biodentine,subdivided into 4 groups under two layers,C+H-MTA group,C+H-Biodentine group and C+H+ MTA group,C+H+Biodentine group.Indirect pulping was performed on the affected teeth according to the grouping conditions.After 2 weeks without any discomfort,the composite resin was permanently filled.Short-term follow-up of 3 months and 6 months after surgery was performed to evaluate the efficacy of the vital pulp therapy(VPT).Statistical analysis: Analysis of efficacy between C+H-MTA group,C+H-Biodentine group,C+H+MTA group and C+H+ Biodentine group,between C+H-layer and C+H+ layer,between MTA and Biodentine two kinds of pulp capping agents were tested by χ2 test.Different cold and thermal stimulating pain degree,cavity texture,cavity color,and the difference between dental caries and control teeth were >10 was analyzed by χ2 test and one-way analysis of variance.Thestatistical difference was defined as P < 0.05.Results:Among the 75 cases,2 cases were inability to contact parents.So,we collected73 cases to analysis.The number of cases including C+H-MTA group,C+H-Biodentine group,C+H+MTA group and C+H+Biodentine group was 15,14,24,20.There were no significant differences in the baseline levels of age,gender,tooth position and cavity type between the 4 groups(P > 0.05).The success rates of indirect pulp capping was 86.67%,100.00%,83.33%,90.00%.There was no significant difference in success rates(P > 0.05).The two cases of MTA and Biodentine two kinds of pulp capping agents were combined.The number of cases in the C+H-layer and C+H+ layers were 29 and 44.There was no significant difference in the baseline levels between the two layers(C+H-layer,C+H+ layer)(P > 0.05).The success rates of indirect pulp capping was93.10% and 86.36%.There was no significant difference in the success rates between the two layers(P > 0.05).In the MTA group and the Biodentine group,the number of cases in the MTA and Biodentine groups was 39 and 34.There was no significant difference in the baseline between the MTA group and Biodentine group(P > 0.05).The success rates were 84.62% and 94.12%(P >0.05;difference,9.5%).The difference which is 9.5was above the inferiority limit of–15%.Biodentine was non-inferior to MTA.Of the 73 cases,65 were treated with successful and 8 were failed.There was no significant difference in the efficacy of different heat stimulating pain degree,cavity texture,cavity color,and the difference in the electrical activity of the teeth and the control teeth between the >10 of the short-term efficacy of indirect pulp capping(P > 0.05).The degree of cold stimulating pain(4.08 ± 2.116)in the successful cases and the degree of cold stimulating pain(6.0±1.852)in the failed cases of reversible pulpitis were statistically different(P < 0.05).Conclusions:Compared with MTA,Biodentine resulted in a non-inferior success rate when used as a indirect pulp capping material for the reversible pulpitis caused by caries ofpermanent teeth.The presence or absence of heat stimulation pain has no effect on the short-term efficacy of indirect pulp capping of reversible pulpitis.The degree of pain caused by cold stimulating has an effect on the short-term efficacy of the treatment of reversible pulpitis.The more severe the degree of cold stimulation,the lower the success rate of indirect pulp capping.