One-year results of vital pulp therapy in permanent molars with irreversible pulpitis: An ongoing multicenter, randomized, non-inferiority clinical trial

摘要

Objectives: 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. Results: 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). Conclusions: 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. Clinical relevance: 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.