Journal of Clinical Pediatric Dentistry. 2025; 49(4): 19-32. doi: 10.22514/jocpd.2025.072
Systematic Review

Vital pulp therapy with a new bioceramic versus calcium hydroxide for young permanent teeth: a meta-analysis

Yanjun Chen1, Chuan Yue2, Dan Xu1, Sumei Wang2, Yanqiao Liu1,*,

1Department of Pediatric Dentistry and Endodontics, Baoding Hospital of Beijing Children’s Hospital Capital Medical University, 071000 Baoding, Hebei, China

2Department of Orthodontics, Baoding Hospital of Beijing Children’s Hospital Capital Medical University, 071000 Baoding, Hebei, China

*Corresponding Author(s):kqky@stu.sqxy.edu.cn (Yanqiao Liu)

History Submitted: 01 November 2024 | Accepted: 30 December 2024 | Published: 03 July 2025
Copyright:  ©2025  The Author(s). Published by MRE Press.
This is an open access article under the CC BY 4.0 license (https://creativecommons.org/licenses/by/4.0/).

Collapse table of contents

Abstract

Background: Vital pulp therapy (VPT) helps to promote the continued physiological development of the apical foramen of young permanent teeth apical foramen. iRoot® BP Plus is a newly developed and might be potential to replace the current materials used in VPT. The aim of this study was to compare the outcomes of iRoot® BP Plus and calcium hydroxide (CH) in VPT for young permanent teeth. Methods: A systematic literature search was conducted in PubMed, Cochrane library, Ovid, Wiley, Chinese National Knowledge Infrastructure, SinoMed and China Science, and Technology Journal Database. Studies that evaluated the effects of VPT on pulp exposed young permanent teeth with iRoot® BP Plus or CH were included in the study. Bias evaluation classified literature into subgroups based on bias risk. Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess evidence quality, and a fixed-effects model was used to analyze clinical success. Results: A total of 21 studies met the inclusion criteria. Of these, 10 studies reporting outcomes at both 6th and 12th months post-surgery were included in the quantitative analysis, respectively. The clinical success of iRoot® BP Plus was superior to CH (Relative risk (RR) = 1.11, 95% confidence interval (CI): 1.04–1.18; RR = 1.10, 95% CI: 1.03–1.16). Descriptive analysis of dentin bridge (DB) formation and DB thickness showed high heterogeneity between iRoot® BP Plus and CH. Conclusions: Based on low- and moderate-risk-of-bias studies, clinical success of iRoot® BP Plus was higher than CH at the 6th and 12th months post-surgery in pulpotomy for young permanent teeth with crown fracture-induced pulp exposure. DB formation differed significantly between the two materials, warranting further investigation. The PROSPERO Registration: The protocol was registered in PROSPERO (CRD42021278982).

Keywords:iRoot® BP;Calcium hydroxide;Pulpotomy;Young permanent teeth;Meta-analysis
PDF(3.32 MB)|EndNote (RIS)|BibTeX|RefMan|RefWorks

Cite this article

Yanjun Chen, Chuan Yue, Dan Xu, Sumei Wang, Yanqiao Liu. Vital pulp therapy with a new bioceramic versus calcium hydroxide for young permanent teeth: a meta-analysis. Journal of Clinical Pediatric Dentistry. 2025; 49(4): 19-32. doi: 10.22514/jocpd.2025.072

1. Introduction

Young permanent teeth are characterized by recent eruptions, incomplete apical development. These teeth typically present with incomplete apical formation and thin root walls [1]. Pulp exposure of these teeth may cause pulp necrosis and developmental arrest. Therefore, preserving living pulp is essential when treating young permanent teeth. Vital pulp therapy (VPT) promotes reparative dentin formation [2] to eliminate pulpitis and preserve pulp vitality. This helps to promote the continued physiological development of the apical foramen of young permanent teeth’ apical foramen. VPT is therefore considered a promising individualized therapy for irreversible pulpitis [3]. Young permanent teeth with pulp exposure are commonly treated with direct pulp capping (DPC) and pulpotomy [4]. DPC places dental materials on the wound surface of the exposed pulp to accelerate protective barrier formation [5]. Pulpotomy is a technique that removes as much inflammatory dental pulp tissue as possible to ensure the capped pulps are all healthy, and covers the cross section of the affected pulp with a pulp capping material to preserve healthy pulp tissue, which is divided into complete and partial pulpotomy according to the extent of the removal of infected pulp [6].

In addition to good antibacterial, anti-inflammatory, biocompatibility and sealing properties, the ideal pulp capping material should also induce dentin mineralization [3, 7]. Since it meets all of these criteria, calcium hydroxide (CH) is the “gold standard” material for pulp capping in history [8]. It can induce necrosis and apoptosis in adjacent cells. It creates an alkaline environment to stimulate the formation of a continuous layer of dentin-like tissues, called a dentin bridge (DB), over the remaining healthy pulp [9, 10]. The wound healing process preserves pulp vitality and prevents bacteria from entering the remaining pulp tissues, thereby ensuring subsequent neogenesis of healthy pulp tissue and repair of dental pulp [9].

iRoot® BP Plus (Innovative Bioceramix Inc, Vancouver, Canada) is a newly developed, convenient, and ready-to-use calcium silicate-based ceramic [11]. iRoot® BP Plus contains tricalcium silicate, zirconium oxide, tantalum pentoxide, dicalcium silicate, calcium sulfate, calcium phosphate monobasic and filler agents. Moreover, it is biocompatible, insoluble and produces caustic calcium hydroxide when in contact with water. As well as not shrinking during setting, it has an antimicrobial effect due to its pH above 12 [12]. Due to its excellent biocompatibility and inductivity in dental pulp cell proliferation and reparative dentin bridge formation, iRoot® BP Plus might be potential to replace the current materials used in VPT [13].

Several studies [14, 15] report higher success rates using iRoot® BP Plus over CH, while others [16, 17] report no differences. In addition, while CH has been proven effective for VPT over the past few decades, iRoot® BP Plus is a relatively new bioceramic material and has only undergone a handful of controlled clinical trials. A review [18] found that iRoot® BP is associated with high clinical and radiographic success for permanent teeth, but its overall clinical effectiveness is uncertain. Most importantly, there is a lack of a systematic review and meta-analysis of CH compared to iRoot® BP VPT for young permanent teeth. To provide a clinical reference, we conducted a systematic review and meta-analysis to make this comparison conclusive.

2. Methods

2.1 Protocol and registration

This meta-analysis was designed and conducted according to the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analysis) standard in the Cochrane Handbook for Systematic Reviews of Interventions [19]. The complete checklist file has been added in the Supplementary material. The protocol was registered in PROSPERO (CRD42021278982).

2.2 Search strategy

A systematic literature search was conducted up to September 2024 in electronic databases, including PubMed, Cochrane Library, Ovid, Wiley, Chinese National Knowledge Infrastructure, SinoMed and China Science and Technology Journal Database. MeSH terms (medical subject headings) were used to conduct the literature search. Boolean operators AND and OR were used in different combinations with the keywords iRoot, bioceramic, pulpotomy, pulp and capping. Detail information was provided in Table 1.

Table 1.Details of literature search.
Database searchedSearch termsNumbers of yields
PubMed[“iRoot” [All Fields] OR [“bioceramic” [All Fields] OR “bioceramics” [All Fields]]] AND [[[“pulpotomy” [MeSH Terms] OR “pulpotomy” [All Fields] OR “pulpotomies” [All Fields]] AND [“dental pulp” [MeSH Terms] OR [“dental” [All Fields] AND “pulp” [All Fields]] OR “dental pulp” [All Fields] OR “pulp” [All Fields]]] OR [“capped” [All Fields] OR “capping” [All Fields] OR “cappings” [All Fields]]]333
Cochrane library[iRoot OR bioceramic] AND [pulpotomy OR pulp OR capping]118
Ovid
[1] iroot.mp. (mp = tx, bt, ti, ab, ct, sh, ot, nm, hw, fx, kf, ox, px, rx, an, ui, ds, on, sy, ux, mx)670
[2] bioceramic.mp. (mp = tx, bt, ti, ab, ct, sh, ot, nm, hw, fx, kf, ox, px, rx, an, ui, ds, on, sy, ux, mx)
[3] pulpotomy.mp. (mp = tx, bt, ti, ab, ct, sh, ot, nm, hw, fx, kf, ox, px, rx, an, ui, ds, on, sy, ux, mx)
[4] pulp.mp. (mp = tx, bt, ti, ab, ct, sh, ot, nm, hw, fx, kf, ox, px, rx, an, ui, ds, on, sy, ux, mx)
[5] capping.mp. (mp = tx, bt, ti, ab, ct, sh, ot, nm, hw, fx, kf, ox, px, rx, an, ui, ds, on, sy, ux, mx)
[6] 1 or 2
[7] 3 or 4 or 5
[8] 6 and 7
Wiley[iRoot OR bioceramic] AND [pulpotomy OR pulp OR capping]1563
Chinese National Knowledge Infrastructure
[1] pulpotomy OR pulp OR capping334
[2] iRoot OR bioceramic
[3] 1 and 2
SinoMed[[“capping” [All Fields] OR [“pulp” [All Fields] OR “pulp” [MeSH Terms]] OR “pulpotomy” [All Fields]] AND [“bioceramic” [All Fields] OR “iroot” [All Fields]]]405
China Science and Technology Journal DatabaseM = [iroot OR bioceramic] AND M = [pulpotomy OR pulp OR capping]149
MeSH: medical subject headings.

2.3 Inclusion criteria

This study was designed based on the PICOS principles, as described below:

P (population): Patients aged 6 to 18 years, with the apical foramen not completely closed on radiographic imaging; patients with young permanent teeth with caries removal-induced pulp exposure and no pulpitis before surgery; patients with traumatic crown fracture-induced pulp exposure and absence of root fracture or root fracture less than 3 mm below gingival margin; patients without obvious periapical lesions; and patients with pulp wounds with hemostatic potential.

I (intervention): iRoot® BP Plus was applied to DPC or pulpotomy.

C (control): CH was applied to DPC or pulpotomy.

O (outcome): The primary outcome was clinical success defined as the absence of subjective symptoms including spontaneous pain, percussion pain, soft tissue swelling and sinus tract formation, or the absence of pulpal pathosis on postoperative radiological tests, including external or internal root resorption, periapical radiolucency, as well as normal results on electrometric pulp testing or the continuous root apex development. The secondary outcome was DB formation defined as complete or incomplete calcium compound or calcification bridge formation on the pulp section based on radiographic findings.

S (study type): Randomized controlled trials (RCTs) and retrospective nonrandomized trials (RNTs).

2.4 Exclusion criteria

(1) Repeatedly detected or published studies; (2) Studies without reported outcome indicators or insufficient data to extract; (3) Studies with patients followed for less than 6 months.

2.5 Study selection and data extraction

All search records were imported into EndNote X8 (Thomson Corporation, Stanford, CT, USA) before eliminating duplicates. Two reviewers (Chen and Yue) independently screened the literature according to inclusion and exclusion criteria, reading titles, abstracts and full texts. In case of disagreement, a third reviewer (Liu) was consulted to reach a majority consensus. The following data were extracted: the first author, publication date, reasons for pulp exposure, treatment procedure, tooth type, quantities of teeth treated, pulp capping material, follow-up time, outcome indicators and study design. Only the control and experimental groups associated with our present study were extracted if studies involved multiple groups.

2.6 Methodological quality assessment

Two investigators independently evaluated the risk of bias in the included studies and cross-checked the results. To resolve any disagreements, a third investigator was consulted. To assess the quality of the included studies, the Cochrane Manual 5.1.0 RCTs bias risk assessment tool was used [19]. The quality of the included studies was divided into low, moderate and high risk. Low risk studies were randomized, double-blind, and free of other important potential biases [20]. Whenever an RCT criterion was high bias, the study was classified as high risk. The bias risk of all other studies was moderate. Finally, the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) system was used to assess the quality of evidence for the reported outcomes.

2.7 Statistical analysis

All statistical analysis and testing were performed by Chen using Revman 5.3 (The Cochrane Collaboration, Oxford, UK). The standard chi-square test and I2 statistic were used to test heterogeneity among studies. Heterogeneity was classified as “not important” (0% to 40%), “moderate” (30% to 60%), “substantial” (50% to 90%) or “considerable” (75% to 100%), as reported in the Cochrane Handbook [19]. Therefore, if I2 < 50%, outcomes were evaluated using a fixed-effects mode, and I2 > 50% was considered to represent substantial heterogeneity. Subsequently, a sensitivity analysis or subgroup analysis was performed to determine the results stability according to possible heterogeneity factors (causes of pulp exposure, treatment methods, literature quality, etc.). When heterogeneity was too high and the source could not be determined, descriptive analysis was used. Relative risk (RR) and 95% confidence intervals (CI) were then calculated and applied to compare clinical success and DB formation between iRoot® BP Plus and CH. Standardized mean difference and 95% CI were calculated and used to compare DB thickness.

3. Results

3.1 Characteristics of the included studies

As shown in Fig. 1 for the flow diagram of the search and selection, 3572 relevant studies were retrieved preliminarily, and 21 studies were finally included after multiple screenings [11, 14, 15, 16, 17, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36]. Participants ranged from 6 to 18 years of age, with 743 experiment teeth and 750 control teeth (all of which were young permanent teeth). Characteristics of the identified studies were presented in Tables 2 and 3. Separately, 16 studies and 14 studies compared the clinical success of iRoot® BP Plus with CH at the 6th and 12th month post-surgery. At the 6th and 12th months post-surgery, 10 and 7 studies examined DB formation rates, respectively, and 3 and 2 studies compared DB thickness at the 1st and 2nd year post-surgery, respectively.

Flow diagram of selected and included studies. CNKI: Chinese National Knowledge Infrastructure; VIP: China Science and Technology Journal Database.

Fig. 1.Flow diagram of selected and included studies. CNKI: Chinese National Knowledge Infrastructure; VIP: China Science and Technology Journal Database.

Table 2.Characteristics of studies included in meta-analysis.
Included studiesStudy settingCountryStudy designRisk evaluation
Huimin Wang, 2021Hospital of Stomatology, Hebei Medical UniversityChinaRandomized controlled trialModerate
Meili Ding, 2018Hospital of Stomatology, Peking UniversityChinaRandomized controlled trialModerate
Qian Rao, 2020Department of Pediatric Dentistry, School and Hospital of Stomatology, Wuhan UniversityChinaRetrospective nonrandomized trialsHigh
Shen Xie, 2019Jiangbei VIP Clinic, Huizhou Stomatological HospitalChinaRetrospective nonrandomized trialsHigh
Ting Sun, 2021Hospital of Stomatology of Yinchuan CityChinaRandomized controlled trialModerate
Weiwei Chen, 2021Department of Stomatology, Shunyi Hospital, Beijing Hospital of Traditional Chinese MedicineChinaRandomized controlled trialHigh
Yan Song, 2019Stomatological Branch Institute of Chongqing Three Gorges Central HospitalChinaRandomized controlled trialModerate
Yanmin Jia, 2020Department of Stomatology, Affiliated Hospital of Inner Mongolia Medical UniversityChinaRandomized controlled trialModerate
Yingting Yang, 2020Department of Pediatric Dentistry, Peking University School and Hospital of StomatologyChinaRandomized controlled trialLow
Xiaohong Wan, 2018Department of Stomatology, First Hospital of Shanxi Medical UniversityChinaRandomized controlled trialModerate
Jinxia Lei, 2019Department of Pediatric Dentistry, Xiangyang Stomatological HospitalChinaRandomized controlled trialHigh
Lijie Xu, 2021Department of Stomatology, Xilin Gol League Central HospitalChinaRandomized controlled trialModerate
Xingmeng Cui, 2020Department of Stomatology, Affiliated Hospital of North China UniversityChinaRandomized controlled trialHigh
Yanxia Zhao, 2021Department of Comprehensive, the First Affiliated Hospital of Zhengzhou UniversityChinaRetrospective nonrandomized trialsHigh
Yanhong Lu, 2022Department of Pediatric Stomatology, Affiliated Stomatological Hospital of Xiamen Medical CollegeChinaRandomized controlled trialLow
Xueyin Yang, 2024Department of Stomatology, Affiliated Hospital of Inner Mongolia Medical UniversityChinaRetrospective nonrandomized trialsHigh
Juan Cao, 2023Department of Pediatric Stomatology, Stomatological Hospital of YinchuanChinaRetrospective nonrandomized trialsHigh
Yan Gao, 2024Department of Stomatology, Suzhou Industrial Park Xingtang HospitalChinaRandomized controlled trialModerate
Wenxiong Xu, 2024Department of Stomatology, Wenzhou Hospital of Integrated Traditional Chinese and Western MedicineChinaRetrospective nonrandomized trialsHigh
Yvzhi Wu, 2022Stomatological center of Suining Central HospitalChinaRandomized controlled trialHigh
Le Zhang, 2021Department of Stomatology, Affiliated Hospital of Yan’an UniversityChinaRandomized controlled trialModerate
VIP: very important person.
Table 3.Characteristics of studies included in meta-analysis.
Included studiesAge (yr)Teeth typeCauses of pulp exposureTreatment procedureNo. of BPNo. of CHInformation of CHFollow-up time (mon)Outcome
Huimin Wang, 20217–9Anterior teethCrown fracturePulpotomy4848Vitapex®12Clinical success, DB
Meili Ding, 20187–12Anterior teethCrown fracturePulpotomy2219Self-making, hand mixed and containing iodine1, 3, 6, 12Clinical success, DB
Qian Rao, 20205.9–13Anterior teethCrown fracturePulpotomy6266GuanYa®12Clinical success
Shen Xie, 20196–18Anterior, posterior teethCarious exposureDPC or pulpotomy3030N12Clinical success
Ting Sun, 20217–12NCrown fracturePulpotomy3636Hand mixed6, 12Clinical success
Weiwei Chen, 20219–10Anterior teethCrown fracturePulpotomy2020Powder and liquid, hand mixed3, 6, 12Clinical success
Yan Song, 20197–15Anterior and posterior teethCarious exposurePulpotomy3535N3, 6, 12Clinical success
Yanmin Jia, 20207–8Anterior teethCrown fracturePulpotomy3333Dycal®3, 6, 12Clinical success
Yingting Yang, 20207–12Anterior teethCrown fracturePulpotomy5049Powder and liquid, hand mixed1, 3, 6, 12, 18, 24Clinical success
Xiaohong Wan, 20188.5–10.5Anterior teethCrown fracturePulpotomy1518N; Longly Biomedicine Co., Ltd.1, 3, 6, 12Clinical success
Jinxia Lei, 20198–10Anterior teethCrown fracturePulpotomy4040Powder and liquid, hand mixed; Shanghai Eryi Zhangjiang Biomedicine Co., Ltd.3, 6Clinical success, DB
Lijie Xu, 20216–14NCarious exposure, crown fractureDPC2928Dycal®6Clinical success, DB
Xingmeng Cui, 20207–16NCarious exposureDPC3030Dycal®3, 6, 12DB
Yanxia Zhao, 20217–12Anterior teethCrown fracturePulpotomy4955Hand mixed; Shanghai Eryi Zhangjiang Biomedicine Co., Ltd.1, 3, 6, 12, 24DB
Yanhong Lu, 20226–12Anterior teethCrown fracturePulpotomy3434Dycal®3, 6, 9Clinical success
Xueyin Yang, 20248–13NCarious exposure, crown fracturePulpotomy2020N3, 6Clinical success, DB
Juan Cao, 20238–12NCarious exposureDPC4244N3, 6, 12Clinical success, DB
Yan Gao, 202413–17NCarious exposure, crown fractureDPC4343Dycal®6, 12Clinical success, DB
Wenxiong Xu, 20247–11Anterior teethCrown fracturePulpotomy4542N3, 6, 12Clinical success, DB
Yvzhi Wu, 20226–12NCrown fracturePulpotomy3030Dycal®1, 3, 6, 12Clinical success, DB
Le Zhang, 20216–13Anterior teethCarious exposure, crown fracturePulpotomy3030Powder and liquid, hand mixed, Longly Biomedicine Co., Ltd.6Clinical success
DB: dentin bridge; DPC: direct pulp capping; CH: calcium hydroxide; BP: iRoot BP Plus; N: not mentioned.

3.2 Risk of bias assessment

The risk of bias in 15 RCTs and 6 RNTs was assessed using the Cochrane Collaboration’s tool (Fig. 2) according to the risk assessment criteria for RCTs described above. The risk of bias (low, moderate or high risk) in the included studies (Table 2).

Risk of bias summary of the included studies. +: low risk; −: high risk; ?: unclear risk.

Fig. 2.Risk of bias summary of the included studies. +: low risk; −: high risk; ?: unclear risk.

3.3 Quality assessment

GRADE method was used to evaluate the evidence quality of studies involving clinical success at the 6th and 12th months in the present meta-analysis. The studies were all conducted in China and only published literature was included, so publication bias was strongly suspected. Based on this, the evidence at the 6th and 12th months based on low- and moderate-risk-of-bias studies was both given a final GRADE score of moderate. Further, due to observational studies, high-risk-of-bias at the 6th and 12th months was given a very low score (Fig. 3).

Clinical success of BP and CH pulpotomies for crown fracture-induced pulp exposure at the 6th and 12th months post-surgery. CH: calcium hydroxide; GRADE: Grading of Recommendations Assessment, Development and Evaluation; RCTs: Randomized controlled trials; RNTs: retrospective nonrandomized trials; BP: iRoot BP Plus.

Fig. 3.Clinical success of BP and CH pulpotomies for crown fracture-induced pulp exposure at the 6th and 12th months post-surgery. CH: calcium hydroxide; GRADE: Grading of Recommendations Assessment, Development and Evaluation; RCTs: Randomized controlled trials; RNTs: retrospective nonrandomized trials; BP: iRoot BP Plus.

3.4 Meta-analysis

3.4.1 Clinical success

Sixteen studies were included which explored clinical success at the 6th month post-surgery and revealed high heterogeneity (χ2 = 56.78, p < 0.00001, I2 = 74%). Sensitivity analysis showed heterogeneity decreased after 6 studies involving carious pulp exposure were excluded (χ2 = 25.55, p = 0.002, I2 = 65%). Subsequently, a subgroup analysis was performed based on the above-graded literature quality (Fig. 4). This analysis showed insignificant heterogeneity among studies with low- and moderate-risk-of-bias (χ2 = 9.89, p = 0.08, I2 = 49%). In a fixed-effects model, clinical success was significantly higher for the BP group (RR = 1.11, 95% CI: 1.04–1.18).

A forest plot of the RR of the 6th month post-surgery. CH: calcium hydroxide; CI: confidence intervals; BP: iRoot BP Plus; M-H: Matel-Haenszel.

Fig. 4.A forest plot of the RR of the 6th month post-surgery. CH: calcium hydroxide; CI: confidence intervals; BP: iRoot BP Plus; M-H: Matel-Haenszel.

Fourteen studies were included which explored clinical success at the 12th month post-surgery and revealed high heterogeneity (χ2 = 68.96, p < 0.00001, I2 = 81%). As with the 6th month studies, a sensitivity analysis was conducted. After 4 studies involving carious pulp exposure were excluded, heterogeneity decreased (χ2 = 25.15, p = 0.003, I2 = 64%). Next, a subgroup analysis was performed based on the assessed risk of bias (Fig. 5). This did not reveal significant heterogeneity among studies with low- and moderate-risk-of-bias (χ2 = 8.02, p = 0.16, I2 = 38%). As with the 6th month case, the BP group had significantly higher clinical success in a fixed-effects mode (RR = 1.10, 95% CI: 1.03–1.16).

A forest plot of the RR of the 12th month post-surgery. CH: calcium hydroxide; CI: confidence intervals; BP: iRoot BP Plus; M-H: Matel-Haenszel.

Fig. 5.A forest plot of the RR of the 12th month post-surgery. CH: calcium hydroxide; CI: confidence intervals; BP: iRoot BP Plus; M-H: Matel-Haenszel.

3.4.2 Dentin bridge formation

A total of 10 and 7 studies were included to investigate DB formation at the 6th and 12th months post-surgery, respectively. Both timeframes had high heterogeneity (χ2 = 31.16, p = 0.0003, I2 = 71%; χ2 = 50.88, p < 0.0001, I2 = 90%). There were 3 and 2 studies that explored DB thickness at the 1st and 2nd year post-surgery, respectively, which showed high heterogeneity (χ2 = 82.60, p < 0.00001, I2 = 98%; χ2 = 114.99, p < 0.00001, I2 = 99%). A sensitivity analysis, however, did not reveal the source of heterogeneity in any of these analyses.

4. Discussion

Recent epidemiological studies have shown an increasing trend in dental trauma among pediatric populations [37], and deep caries are also prevalent in children and adolescents. This review included all studies involving caries removal- or crown fracture-induced pulp exposure, with high heterogeneity found both at the 6th and 12th months post-surgery (I2 = 74%, 81%, respectively). I2 decreased when studies involving carious pulp exposure treated with DPC were excluded (I2 = 65%, 64%, respectively). Hence, VPT clinical success may be affected by pulp exposure and its treatment in young permanent teeth. VPT can achieve good efficacy as long as healthy pulp tissue is preserved after infected tissue is removed thoroughly [38]. Response to pulp exposure depends on pulp state and bacterial contamination potential [39]. To date, there is no accurate method to determine the infection status of pulp tissues, distinguish reversible pulpitis from irreversible pulpitis or determine the extent of bacterial infection [38].

There has been a long history of the use of DPC and pulpotomy in the treatment of traumatic crown-fracture-induced pulp exposure, primarily because bacterial infection is more difficult to diagnose in carious pulp exposure. Compared to pulpotomy, DPC is more likely not to fully remove the infected pulp. In this review, only a few studies focused on carious pulp exposure and DPC at the 6th and 12th months, so the detailed causes of the observed heterogeneity cannot be determined. More related studies will be needed to address this in the future.

A subgroup analysis was conducted according to the quality of the literature concerning crown-fracture-induced pulp exposure because heterogeneity was still high after excluding the studies involving carious pulp exposure at the 6th and 12th months post-surgery. Clinical success in the BP group was higher than in the CH group at the 6th and 12th months post-surgery. iRoot® BP Plus had an antimicrobial effect [40]. According to Zhang et al. [41], iRoot® BP Plus was nontoxic and able to induce mineralization and odontoblastic differentiation-associated gene expression in human dental pulp cells. Wang et al. [42] also found that iRoot® BP Plus demonstrated good biocompatibility in in-vitro tests and also promoted proliferative activity in human dental pulp stem cells. It promoted cell adhesion, migration and attachment, as well as osteogenic differentiation. Accordingly, iRoot® BP Plus is ideal for pulp capping young permanent teeth. Compared to iRoot® BP, CH is a strong alkali with strong cytotoxicity and no anti-inflammatory effect [43]. Therefore, it exhibits higher toxicity to human dental pulp cells. This results in significantly higher cell death and apoptosis and inhibition of human dental pulp cell proliferation [10].

Damaged pulp tissue, which is much closer to the surface without a DB, is more susceptible to further invasion by oral bacteria and their by-products. Degeneration and atrophy may also occur in free pulp tissues caused by avoiding dentin. Therefore, it appears that a DB is the most effective solution for healing and long-term success [44]. We analyzed the difference in DB formation rate between iRoot® BP Plus and CH in VPT for young permanent teeth with pulp exposure. Both groups showed a high degree of heterogeneity at the 6th and 12th months, possibly due to different CH components used in different studies. According to the findings regarding bacterial biofilm [45], iodoform paste (containing iodoform only) and Vitapex (containing iodoform) both show stronger resistance to bacterial biofilm than CH alone. Iodoform has no tissue-stimulating properties and can absorb pulp wound exudation when it is added to pulp capping material to improve the bactericidal effect, thereby producing a synergistic effect for pulp repair [46]. Various other factors may contribute to high heterogeneity, including a small number of studies included, different reasons for pulp exposure and treatment methods in different studies, and differences in overall literature quality.

CH, a commonly used direct pulp capping material, depends on its ability to seal exposed pulp [9]. In this meta-analysis, DB thickness between the BP and CH groups was compared, but only three studies were included. Based on one-year follow-up, it was found that the DB of the BP group was thicker than that of the CH group [21], According to the two-year follow-up results [16], it was thicker in the CH group than the iRoot® BP Plus group. According to the third study, the DB thickness was not significantly different between both groups according to one-year follow-up findings, but was higher in the iRoot® BP Plus group compared to the CH group at the two-year follow-up [29]. Only these three studies compared DB thickness, all of which were crown fracture-induced pulp exposure, so the inconsistent results may be due to differences in pulp exposure site size, time or other factors. To generate conclusive results, more research is needed.

Radiographic evidence of dentine reaction is not an indicator of pulp therapy success but is instead viewed as a traumatic pulp reaction due to the need for a partial barrier [47]. High-quality DB formation may contribute to VPT success. Asgary et al. [48] found that DB formed by direct pulp capping with CH was likely to be incomplete and associated with varying degrees of inflammation. With time, CH may dissolve and form a dead space. This can induce the formation of many pores in the DB and increase microleakage [49, 50]. According to animal experiments on beagle dogs [51], direct pulp capping with iRoot® BP Plus induced complete DB formation without obvious inflammation. Moreover, iRoot® BP Plus was superior to traditional CH in pulp capping and exhibited good biological properties in a minipig model [52], which may explain its clinical success in treating young permanent teeth in humans.

This meta-analysis still has many limitations, including: (1) Tunnel-type defects of DB under CH may become pathways for microleakage and the material might dissolve over time. Therefore, both follow-up time and final restoration influence the prognosis [8]. Taha adopted CH for pulpotomy, but it failed in more than half of the cases within two years [53]. Due to the history of direct pulp capping with CH and the progressive failure over time, follow-up studies for at least 5 years are recommended to detect dental pulp necrosis [54]. However, this study followed up for only 1 year. More clinical randomized controlled trials with a longer follow-up time are therefore needed. (2) Language and internet search limitations. Online searches were limited to Chinese and English databases. Various materials can be used for VPT. Biodentine and MTA (mineral trioxide aggregate) are most used for VPT in English-language databases. Despite some studies exploring pulp capping with iRoot® BP Plus in other countries, none included a comparison with CH or met the inclusion criteria. The included studies were from regional databases (China), which may have introduced reporting bias. But the literature was rigorously screened by inclusion criteria; a strict quality assessment was conducted for this meta-analysis. Unfortunately, only a few of the included studies were assessed as low risk of bias. Quality assessment of the included studies was carried out using the GRADE method. Low- and moderate-risk-of-bias studies involving clinical success at the 6th and 12th months were given a final GRADE score of moderate. Based on these subgroups, the first conclusion is relatively robust. (3) Inclusion criteria were defined roughly, and randomized controlled trials on this specific topic are lacking in high-quality and standardization. Therefore, DB formation is inaccurately concluded. To obtain more robust results, future studies should be more accurate and larger in size. (4) Publication bias may be present in some outcome indicators. Although an extensive search strategy was implemented, literature such as supplements, conference literature and some gray literature could not be accessed, so potential publication bias cannot be excluded.

5. Conclusions

This study results in the following conclusions:

1. Based on low- and moderate-risk-of-bias studies, clinical success of iRoot® BP Plus was higher than CH at the 6th and 12th months post-surgery in pulpotomy for young permanent teeth with crown fracture-induced pulp exposure.

2. Both DB formation rate and DB thickness showed significant differences in different studies when using iRoot® BP Plus or CH in VPT for young permanent teeth with pulp exposure. Further investigations are needed.

Availability of data and materials

These data are available in the above database.

Author contributions

YJC—collected evidence; wrote and translated the manuscript. CY—collected evidence and performed statistical analysis. DX and SMW—prepared the publishing work. YQL—designed the research study; collected evidence; managed the research activity planning and execution. All authors contributed to editorial changes in the manuscript. All authors read and approved the final manuscript.

Ethics approval and consent to participate

This article does not contain any studies with human participants or animals performed by any of the authors. For this type of study, formal consent is not required.

Acknowledgment

Not applicable.

Funding

This research did not receive any specific grants from funding agencies in the public, commercial, or not-for-profit sectors.

Conflict of interest

The authors declare no conflict of interest.

Supplementary material

Supplementary material associated with this article can be found, in the online version, at https://oss.jocpd.com/ files/article/1940454494834704384/attachment/ Supplementary%20material.docx.

References

Llena C, Hernández M, Melo M, Sanz JL, Forner L. Follow-up of patients subjected to direct and indirect pulp capping of young permanent teeth. A retrospective study. Clinical and Experimental Dental Research. 2021; 7: 429–435.

[Google Scholar]

Wu BL, Luo YF, Xu WA, Tong ZC. Vital pulp therapy of pulp inflammation of permanent teeth. Journal of Prevention and Treatment for Stomatological Diseases. 2021; 29: 433–441. (In Chinese)

[Google Scholar]

Guan X, Zhou Y, Yang Q, Zhu T, Chen X, Deng S, et al. Vital pulp therapy in permanent teeth with irreversible pulpitis caused by caries: a prospective cohort study. Journal of Personalized Medicine. 2021; 11: 1125.

[Google Scholar]

Liu YK, Wang Y, Gu ZY, Wu Q, Xu X, Zhou XD. Efficacy of mineral trioxide aggregate for partial pulpotomy in cariously exposure pulps of young permanent teeth: a meta-analysis. Chinese Journal of Evidence-Based Medicine. 2017; 17: 1437–1441. (In Chinese)

[Google Scholar]

Komabayashi T, Zhu Q, Eberhart R, Imai Y. Current status of direct pulp-capping materials for permanent teeth. Dental Materials Journal. 2016; 35: 1–12.

[Google Scholar]

Wan XH, Yang L. Research progress of clinical methods and pulp capping agent selection in the treatment of young permanent teeth with pulp preservation. Electronic Journal of General Stomatology. 2018; 5: 18–19, 22. (In Chinese)

[Google Scholar]

Caruso S, Dinoi T, Marzo G, Campanella V, Giuca MR, Gatto R, et al. Clinical and radiographic evaluation of biodentine versus calcium hydroxide in primary teeth pulpotomies: a retrospective study. BMC Oral Health. 2018; 18: 54.

[Google Scholar]

Uyar DS, Alacam A. Evaluation of partial pulpotomy treatment in cariously exposed immature permanent molars: randomized controlled trial. Nigerian Journal of Clinical Practice. 2021; 24: 1511–1519.

[Google Scholar]

Darwish SS, Abd El Meguid SH, Wahba NA, Mohamed AA, Chrzanowski W, Abou Neel EA. Root maturation and dentin-pulp response to enamel matrix derivative in pulpotomized permanent teeth. Journal of Tissue Engineering. 2014; 5: 2041731414521707.

[Google Scholar]

Dou L, Yan Q, Yang D. Effect of five dental pulp capping agents on cell proliferation, viability, apoptosis and mineralization of human dental pulp cells. Experimental and Therapeutic Medicine. 2020; 19: 2377–2383.

[Google Scholar]

Rao Q, Kuang J, Mao C, Dai J, Hu L, Lei Z, et al. Comparison of iRoot BP Plus and calcium hydroxide as pulpotomy materials in permanent incisors with complicated crown fractures: a retrospective study. Journal of Endodontics. 2020; 46: 352–357.

[Google Scholar]

Mahgoub N, Alqadasi B, Aldhorae K, Assiry A, Altawili ZM, Tao Hong. Comparison between iRoot BP Plus (endosequence root repair material) and mineral trioxide aggregate as pulp-capping agents: a systematic review. Journal of International Society of Preventive & Community Dentistry. 2019; 9: 542–552.

[Google Scholar]

Liu S, Wang S, Dong Y. Evaluation of a bioceramic as a pulp capping agent in vitro and in vivo. Journal of Endodontics. 2015; 41: 652–657.

[Google Scholar]

Jia YM, Gegentana. Clinical observation of iRoot BP Plus for the treatment of young permanent anterior teeth with crown fracture following pulpotomy. Journal of Practical Stomatology. 2020; 36: 897–900. (In Chinese)

[Google Scholar]

Chen WW, Ren ZM, Zhao LS. Effect of bioceramic iRoot BP Plus vital pulpotomy and immediate repair on crown fractures of young permanent teeth and its influence on pain symptoms. Journal of Clinical and Experimental Medicine. 2021; 20: 440–443. (In Chinese)

[Google Scholar]

Yang Y, Xia B, Xu Z, Dou G, Lei Y, Yong W. The effect of partial pulpotomy with iRoot BP Plus in traumatized immature permanent teeth: a randomized prospective controlled trial. Dental Traumatology. 2020; 36: 518–525.

[Google Scholar]

Ding ML, Qin M, Zheng JJ, Zhang HM, Lin BC, Chen XX. Evaluation of a new bioceramic as pulp capping agent in immature permanent tooth pulpotomies. Journal of Oral Science Research. 2018; 34: 766–770. (In Chinese)

[Google Scholar]

Matoug-Elwerfelli M, ElSheshtawy AS, Duggal M, Tong HJ, Nazzal H. Vital pulp treatment for traumatized permanent teeth: a systematic review. International Endodontic Journal. 2022; 55: 613–629.

[Google Scholar]

Higgins JPT, Green S. Cochrane handbook for systematic reviews of interventions. Version 5.1.0. John Wiley & Sons: UK. 2011.

[Google Scholar]

Bolland MJ, Leung W, Tai V, Bastin S, Gamble GD, Grey A, et al. Calcium intake and risk of fracture: systematic review. British Medical Journal. 2015; 351: h4580.

[Google Scholar]

Wang HM, Zhao ZB, Liu XL, Zhang YN, Hou JY, Yang YT. Clinical effect evaluation of pulpotomy using bioceramic in young permanent anterior teeth. Journal of Hebei Medical University. 2021; 42: 727–729. (In Chinese)

[Google Scholar]

Xie S. Analysis on clinical value of bioceramic iRoot BP Plus in the vital pulp preservation and treatment of young permanent teeth. Clinical Medicine & Engineering. 2019; 26: 867–868. (In Chinese)

[Google Scholar]

Sun T, Liu XJ, Zhang F, Zhang SY. Clinical efficacy of pulpotomy using two different materials in crown fracture exposed young permanent. Ningxia Medical Journal. 2021; 43: 765–766. (In Chinese)

[Google Scholar]

Song Y, Qiu Y. Clinical analysis of iRoot BP Plus vital pulp save material on pulpotomy of young permanent teeth. Chinese Journal of Aesthetic Medicine. 2019; 28: 119–121. (In Chinese)

[Google Scholar]

Wan XH. Clinical observation of new bioceramic materials in the treatment of young permanent teeth with complicated crown [master’s thesis]. Shanxi Medical University. 2018.

[Google Scholar]

Lei JX, Lv BB, Zhang YT. The clinical effectiveness of iRoot BP Plus in immature permanent tooth pulpotomimes. Journal of Clinical Stomatology. 2019; 35: 409–411. (In Chinese)

[Google Scholar]

Xu LJ. Analysis of the effect of direct pulp capping using iRoot BP Plus in young permanent teeth. China Health Care & Nutrition. 2021; 6: 74. (In Chinese)

[Google Scholar]

Cui XM. Clinical efficacy of direct pulp capping using iRoot BP Plus in young permanent teeth. Dietetic and Health-Care. 2020; 20: 33. (In Chinese)

[Google Scholar]

Zhao YX, Zhang P. Clinical effect of iRoot BP Plus in pulpotomy of young permanent teeth. Journal of Chinese Practical Diagnosis and Therapy. 2021; 35: 1029–1032. (In Chinese)

[Google Scholar]

Lu YH, Wang J, Wu XG. Observation of clinical effect and aesthetics of iRoot BP Plus in pulpotomy of young permanent teeth. Chinese Journal of Aesthetic Medicine. 2022; 31: 141–144. (In Chinese)

[Google Scholar]

Yang XY, Jin WL, Gegentana, Li LJ, An LL. Comparative analysis of clinical efficacy of MTA, iRoot BP Plus, and calcium hydroxide in young permanent teeth. Pulpotomy Progress in Modern Biomedicine. 2024; 24: 131–135. (In Chinese)

[Google Scholar]

Cao J, Li SJ, Xu MZ. Clinical observation of new biomaterial for pulp capping treatment of young permanent teeth. Ningxia Medicine Journal. 2023; 45: 1137–1139. (In Chinese)

[Google Scholar]

Gao Y. Analysis of the clinical effectiveness of iRoot BP and Dycal in direct pulp capping treatment of young permanent teeth. World Journal of Complex Medicine. 2024; 10: 12–16. (In Chinese)

[Google Scholar]

Xu WX, Ding S, Li BS, Wang XZ. Effect of pulp capping agents in patients with traumatic crown fracture of permanent anterior teeth and exposed pulp. China Modern Doctor. 2024; 62: 59–62, 66. (In Chinese)

[Google Scholar]

Wu YZ, He M, Liu Y. Effect of different pulp capping agent in the pulpotomy treatment of crown fracture and pulp exposure in children. Translational Medicine Journal. 2022; 11: 222–225. (In Chinese)

[Google Scholar]

Zhang L, Cao WJ, Wang JQ. Comparison of clinical effects of iRoot BP Plus and calcium hydroxide in young permanent anterior pulp amputation. Journal of Yanan University. 2021; 19: 42–45. (In Chinese)

[Google Scholar]

Wang XM, Su XL, Wang H, Liu F, Zhao YP, Guo QY. Prevalence survey of dental trauma to immature permanent teeth in Xi’an schoolchildren. West China journal of stomatology. 2018; 36: 194–198. (In Chinese)

[Google Scholar]

Xuedong Z, Dingming H, Jianguo L, Zhengwei H, Xin W, Deqin Y, et al. Vital pulp therapy of damaged dental pulp. West China Journal of Stomatology. 2017; 35: 339–347. (In Chinese)

[Google Scholar]

Hsiao J, Wang Y, Zheng L, Liu R, Said R, Hadjiyski L, et al. In vivo rodent models for studying dental caries and pulp disease. Methods in Molecular Biology. 2019; 1922: 393–403.

[Google Scholar]

Damlar I, Ozcan E, Yula E, Yalcin M, Celik S. Antimicrobial effects of several calcium silicate-based root-end filling materials. Dental Materials Journal. 2014; 33: 453–457.

[Google Scholar]

Zhang S, Yang X, Fan M. BioAggregate and iRoot BP Plus optimize the proliferation and mineralization ability of human dental pulp cells. International Endodontic Journal. 2013; 46: 923–929.

[Google Scholar]

Wang J, Fangteng JZ, Liu H. Effect of iRoot BP Plus on biological behavior of deciduous tooth pulp stem cells and human pulp stem cells. Shanghai Journal of Stomatology. 2019; 28: 251–258. (In Chinese)

[Google Scholar]

Han JL. Research and application of the pulp capping material using in the vital pulp conservation treatment. Chinese Journal of Conservative Dentistry. 2004; 14: 291–293. (In Chinese)

[Google Scholar]

Li Z, Cao L, Fan M, Xu Q. Direct pulp capping with calcium hydroxide or mineral trioxide aggregate: a meta-analysis. Journal of Endodontics. 2015; 41: 1412–1417.

[Google Scholar]

Pilownic KJ, Carvalho CN, Romano AR, Morgental RD, Shen Y, Haapasalo M, et al. Antibiofilm activity of five different endodontic filling materials used in primary teeth using confocal laser scanning microscopy. Pediatric Dentistry. 2017; 39: 145–149.

[Google Scholar]

Zhang S, Qin M, Ge LH, Shi GX. Observation on the application of iodoform calcium hydroxide pulp capping agent in vital pulpotomy of deciduous teeth. Journal of Modern Stomatology. 2000; 119–120. (In Chinese)

[Google Scholar]

Waterhouse PJ, Nunn JH, Whitworth JM, Soames JV. Primary molar pulp therapy—histological evaluation of failure. International Journal of Paediatric Dentistry. 2000; 10: 313–321.

[Google Scholar]

Asgary S, Eghbal MJ, Parirokh M, Ghanavati F, Rahimi H. A comparative study of histologic response to different pulp capping materials and a novel endodontic cement. Oral Surgery Oral Medicine Oral Pathology Oral Radiology and Endodontics. 2008; 106: 609–614.

[Google Scholar]

Yang RQ, Wei X. New approaches of vital pulp terapy in permanent teeth. Chinese Journal of Conservative Dentistry. 2017; 27: 410–417. (In Chinese)

[Google Scholar]

Chailertvanitkul P, Paphangkorakit J, Sooksantisakoonchai N, Pumas N, Pairojamornyoot W, Leela-Apiradee N, et al. Randomized control trial comparing calcium hydroxide and mineral trioxide aggregate for partial pulpotomies in cariously exposed pulps of permanent molars. International Endodontic Journal. 2014; 47: 835–842.

[Google Scholar]

Shi S, Bao ZF, Liu Y, Zhang DD, Chen X, Jiang LM, et al. Comparison of in vivo dental pulp responses to capping with iRootBP Plus and mineral trioxide aggregate. International Endodontic Journal. 2016; 49: 154–160.

[Google Scholar]

Chen NN, Zhang Y, Wang YM, Wang LJ, Ling JJ, Zheng Y. Evaluation of bioceramic iRoot BP Plus as a pulp capping agent in swine. Beijing Journal of Stomatology. 2017; 25: 313–316. (In Chinese)

[Google Scholar]

Taha NA, Khazali MA. Partial pulpotomy in mature permanent teeth with clinical signs indicative of irreversible pulpitis: a randomized clinical trial. Journal of Endodontics. 2017; 43: 1417–1421.

[Google Scholar]

Barthel CR, Rosenkranz B, Leuenberg A, Roulet JF. Pulp capping of carious exposures: treatment outcome after 5 and 10 years: a retrospective study. Journal of Endodontics. 2000; 26: 525–528.

[Google Scholar]