One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter, randomized, non-inferiority clinical trial
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Root canal therapy (RCT) and tooth extraction have been conventional treatment options for management of human mature teeth with irreversible pulpitis. Excellent short-term treatment outcomes of vital pulp therapy with calcium-enriched mixture cement (VPT/CEM), as a new treatment option, on postoperative pain relief was demonstrated; if intermediate- and long-term treatment outcomes of the new treatment are also non-inferior compared to RCT, then VPT/CEM may become a viable treatment option for management of mature teeth with irreversible pulpitis.
Materials and methods
In 23 healthcare centers, 407 9- to 65-year-old patients were randomly allocated into two study arms including one-visit RCT (reference treatment; n = 202) and VPT/CEM (alternative treatment; n = 205). Six- and twelve-month clinical and radiographic successes were assessed.
Mean follow-up times at 6- and 12-month follow-ups were “6.70 ± 0.68 and 6.72 ± 0.71 months” and “12.96 ± 0.67 and 12.90 ± 0.66 months” in the available cases of RCT and VPT/CEM arms, respectively. Favorable clinical success rates in the two study arms did not show statistical difference; however, the radiographic success rate in the VPT/CEM was significantly greater than RCT arm at the two follow-ups (P < 0.001). The patients’ age had no effect on the treatment outcomes (P = 0.231).
Treatment outcomes of VPT/CEM may be superior to RCT in mature molars with irreversible pulpitis. The performance of biomaterials such CEM cement may assist in the shift towards more biologic treatments.
VPT/CEM may be a realistic alternative treatment for human mature molar teeth with symptoms of irreversible pulpitis; the use of VPT/CEM is highly beneficial for patients as well as general dentists.
KeywordsBiomaterial Calcium-enriched mixture CEM cement Endodontics Human Molar Pulpitis Pulpotomy Vital pulp therapy
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, M.H. Khoshnevisan, S.M. Tabatabaei, K Etemad, 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.
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].
Conflict of interest
The authors report no conflicts of interest.
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