Abstract
Purpose
The objective of this multicentre randomised controlled trial was to compare the clinical/radiographic outcomes of cervical pulpotomy using calcium-enriched mixture cement (PCEM) and pulpectomy using Metapex (PM) in primary molars with irreversible pulpitis (IP).
Methods
A total of 134 primary molars from 94 children were randomly assigned to two intervention groups: the PCEM group (n = 74) and the PM group (n = 60). Baseline characteristics including age/gender/molar type/tooth type/jaw were recorded. The primary outcome measures were clinical/radiographic success rates assessed at the first and second follow-up appointments. Secondary outcomes included reasons for clinical/radiographic failures. Multiple logistic regression analysis was performed to determine the impact of various factors on the success rates.
Results
The mean age of the participants in both groups was similar (PCEM group: 5.4 years, PM group: 5.5 years). Gender distribution, molar type, tooth type, jaw, and number of practitioners were comparable between the groups. The clinical success rate at the first follow-up was 98.6% in the PCEM group and 96.4% in the PM group. At the second follow-up, the clinical success rate was 97.1% in the PCEM group and 91.1% in the PM group. The radiographic success rates at the first and second follow-up were 98.6% and 96.4% in the PCEM group and 96.4% and 91.1% in the PM group, respectively. Multiple logistic regression analysis did not reveal any significant association between the success rates and age/gender/molar type/jaw, or treatment groups (P > 0.05).
Conclusion
In primary molars with IP, both simple/conservative cervical pulpotomy using calcium-enriched mixture cement and pulpectomy using Metapex demonstrated high clinical/radiographic success rates. No significant differences were observed between the two treatment modalities. These findings suggest that both techniques can be considered effective treatment options for managing primary molars with IP.
Trial registration number
Trial registration number: IRCT20201226049838N1, retrospectively registered on 12 January 2021.
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Abbreviations
- X:
-
Mashhad University of Medical Sciences
- Y:
-
Shahid Sadoughi University of Medical Sciences
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Acknowledgements
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Funding
This project was funded by the Vice-Chancellor for Research, Mashhad University of Medical Sciences, Mashhad, Iran and the Vice-Chancellor for Research, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. The funders had no role/influence in any stages in the process of this research.
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Contributions
SA conceived the ideas; SA, ASS and ZB designed the study; SA and ASS supervised the research; SS, FZ and SS performed clinical procedure/data collection; ASS, ZB and FF supervised clinical procedures and follow-ups performed by one of the operators; AAB performed statistical analysis; SS drafted the manuscript; SA revised/finalised the manuscript.
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Conflict of interest
Dr Saeed Asgary is the inventor of CEM cement (Endodontic Filling Material; USA, 7,942,961, 2011 May 17). All other authors declare that they have no conflict of interest regarding the publication of this paper.
Ethical approval
The protocol of this study was approved by both local ethics committees of Mashhad University of Medical Sciences (IR.mums.sd.REC.1394.242) and Shahid Sadoughi University of Medical Sciences (IR.SSU.REC.1396.152).
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Informed consent was obtained from all individual participants included in this study.
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Sabbagh, S., Bahrololoomi, Z., Sarraf Shirazi, A. et al. Comparative evaluation of cervical pulpotomy and pulpectomy for primary molars with irreversible pulpitis: a multicentre randomised controlled trial. Eur Arch Paediatr Dent (2024). https://doi.org/10.1007/s40368-024-00880-z
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DOI: https://doi.org/10.1007/s40368-024-00880-z