Treatment outcomes of pulpotomy in permanent molars with irreversible pulpitis using biomaterials: A multi-center randomized controlled trial

Abstract

Objective. To conduct a randomized clinical trial to compare the post-operative pain experience as well as clinical and radiographic outcomes of pulpotomy in human permanent molars with irreversible pulpitis using calcium enriched mixture (CEM) cement or mineral trioxide aggregate (MTA). Materials and mcethods. A total of 413 patients met the inclusion criteria and consented to participate. The patients were randomly allocated into two study arms: MTA pulpotomy (PMTA: n = 208) and CEM pulpotomy (PCEM: n = 205). Numerical rating scale questionnaires were utilized by the patients to record pain intensity (PI) over 7 days post-operatively. The patients were followed-up for 12 months to assess the clinical and radiographic outcomes of treatment. The data was analyzed using Chi-square, Cohen's kappa and t-tests. Results. There was no significant difference in the mean PI recorded during the 7 post-operative days between the two study arms (p = 0.221). The clinical and radiographic success rates for PMTA at 12-month follow-up were 98 and 95%, respectively; and 97 and 92% for PCEM, respectively. There was no significant differences in clinical (p = 0.7) and radiographic (p = 0.4) success rates between the two arms. Conclusions. Excellent treatment outcomes occurred in molar teeth with irreversible pulpitis undergoing pulpotomy with MTA and CEM biomaterials.

Key Words::

• calcium enriched mixture
• CEM
• human
• permanent tooth
• pulpitis
• pulpotomy

Acknowledgment

This work was supported by the Iranian Ministry of Health and Medical Education (Health Deputy, Oral Health Office) and Shahid Beheshti University of Medical Sciences [grant number p/25/17/1/tm/103]. The authors thank the study participants and dentists (Drs S. Niknam, H. Abdolmaleki, M. Shahriari, B. Sepehri, M. Zarei, H. Mohadesi, L. Kochmeshki, N. Shirzaei, S. H. Hoseini, M. R. Naderi, A. R. Torkamanzadeh, N. Sahranavard, J. Mohebi, A. Naseri, M. Forozanfar, A. Razavi, A. Izadi, H. Fadaei, K. Khorshidian, H. A. Taheri, M. H. Bagheri-Atabak, M. Zareshahi and M. Pahlevan- Shamsi) for their enthusiastic contributions; as well as Drs K. Bagheri-lankarani, S. H. Emami-Razavi, S. M. Alavian, A. R. Mesdaghinia, M. M. Goya, K. Etemad, M. H. Khoshnevisan, S. M. Tabatabaei, M. M. Vardi, M. Sourosh and H. Hesary, who provided the national supervision of and support for this trial; Dr S. M. R. Safavi for critical review; Drs A. R. Zali, S. Mohamad-Sadeghi, M. R. Razzaghi, M. Piriaei and S. Kheirieh for administrative help; Drs A. Akbarzadeh and M. J. Kharazi-Fard, who helped to develop the original statistical design/analysis; Drs R. A. Taheri, F. Rahnama, A. Heravi, G. A. Dehghani and H. Fotohi, who monitored the trial in different states; Dr E. Soheilipour, M. Ghorbanpour, B. Shadman, O. Hosseini and Z. Khademi, who entered and checked the data; Drs H. Nazarinia and S. Goorang, who interpreted the x-rays; and Dr L. Alim Marvasti for the English editing of the manuscript.

Declaration of interest: The authors alone are responsible for the content and writing of the paper. Prof. Saeed Asgary is the inventor of calcium enriched mixture (CEM) cement (Endodontic Filling Material; USA, 7,942,961, 2011 May 17).