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Journal of Peking University (Health Sciences) ›› 2024, Vol. 56 ›› Issue (6): 1083-1088. doi: 10.19723/j.issn.1671-167X.2024.06.022

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A randomized controlled trial of iRoot BP Plus used as pulp capping agent in the complex fracture of young permanent tooth

Yingting YANG1, Ruozhu LI2, Guili DOU2, Yue LEI1, Bin XIA2,*()   

  1. 1. Third Clinical Division, Peking University School and Hospital of Stomatology & National Center for Stomatology & National Clinical Research Center for Oral Diseases & National Engineering Research Center of Oral Biomaterials and Digital Medical Devices, Beijing 100191, China
    2. Department of Pediatric Dentistry, Peking University School and Hospital of Stomatology, Beijing 100081, China
  • Received:2021-08-17 Online:2024-12-18 Published:2024-12-18
  • Contact: Bin XIA E-mail:xiabin@pkuss.bjmu.edu.cn

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Abstract:

Objective: To investigate the clinical and radiographic outcomes of 3 years after partial pulpotomy with iRoot BP Plus in immature permanent teeth with complex crown fracture and to provide refe-rence for the clinical application. Methods: The study was prospectively designed and 104 immature permanent teeth with complex crown fracture were randomly allocated into two groups (n=52). The experiment group received iRoot BP Plus as the pulp capping agent while the control group received calcium hydroxide as the pulp capping agent. After partial pulpotomy, all teeth were clinically and radiographically assessed at the end of 1, 3, 6, 12, 18, 24, 30, and 36 months. The success rate in the two groups was evaluated to see if there was significant difference. The root canal wall thickness in the treated teeth was compared both between the groups and within the groups with those of the corresponding healthy teeth on the opposite side, in the same patient. Results: Excluding those lost to follow-up, there were 44 teeth in calcium hydroxide group (8 teeth accounting for 15.4% were lost to follow up) and 45 teeth in iRoot BP Plus group (7 teeth accounting for 13.5% were lost to follow up) in the end. There was no intergroup difference in the success rate between calcium hydroxide group and iRoot BP Plus group (per-protocol analysis: 80% vs. 87%; intent-to-treat analysis: 67% vs. 75%). The non-inferiority margin was -10%. The 95% confidence interval of the difference in success rate was -8% to 22%. There was no significant difference in root development between the experimental teeth and contralateral control teeth. The thickness of upper 1/3 root canal in the iRoot BP Plus group was thinner than that in the CH group [(1.82±0.21) mm vs. (1.91±0.20) mm, P=0.047]. Conclusion: iRoot BP Plus used in pulpotomy can effectively preserve the living pulp and promote the development of root in the young permanent teeth with complex crown fracture.

Key words: Permanent teeth, Tooth Fractures, Pulpotomy, Pulp capping and pulpectomy agents, Child

CLC Number: 

  • R788.4

Figure 1

The measurement of root canal wall thickness The root canal wall thickness = $ \frac{1}{2}$ AD-$ \frac{1}{2}$ BC. AD, the width of the pulp space; BC, the width of the root."

Table 1

Basic information of the teeth"

Items CH group (n=52) iRoot group (n=52)
Teeth type
  11 25 (48) 27 (52)
  21 25 (48) 23 (44)
  41 2 (4) 2 (4)
Consulting time
  ＜24 h 29 (56) 34 (65)
  24-48 h 7 (13) 10 (20)
  ＞48 h 16 (31) 8 (15)

Figure 2

The radiograph of a successful and a failure case in the iRoot group over different follow-up periods On the figures shown above, the right incisor with complicated crown fracture received iRoot capping the pulp, after 3, 12, 24, 36 months. The apical foreman is smaller, the root canal wall was thickened and the periapical bone density was normal. On the figures shown below, the left incisor with complicated crown fracture received iRoot capping the pulp. A periapical radiolucency was found on the follow-up radiograph at 24 months radiograph and apexification was initiated."

Table 2

The success rate of intent-to-treat analysis and per-protocol analysis"

ItemsIntent-to-treat analysis Per-protocol analysis
CH group iRoot group CH group iRoot group
Survival number 35 39 35 39
Total number 52 52 44 45
Survival rate 67% 75% 80% 87%
95%CI 55%-80% 63%-86% 68%-91% 77%-96%
P 0.33 0.38

Table 3

The comparison of the thickness (mm) of root canal wall of the maxillary right incisor"

Group2/3 point (lower) 1/3 point (upper)
Teeth after the pulpotomy Adjacent normal teeth P Teeth after the pulpotomy Adjacent normal teeth P
CH (n=25) 1.45±0.19 1.45±0.22 0.939 1.91±0.20 1.83±0.21 0.081
iRoot (n=27) 1.41±0.20 1.44±0.17 0.266 1.82±0.21 1.80±0.20 0.480
P 0.310 0.761 0.047 0.462
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