Two-year results of vital pulp therapy in permanent molars with irreversible pulpitis: an ongoing multicenter randomized clinical trial

Abstract

Oral healthcare expenses are increasing rapidly as a result of the growth of high-cost health technologies worldwide. In many developing/developed countries, low-cost tooth extraction is the alternative treatment option for a high-cost root canal therapy (RCT) for management of human molars with irreversible pulpitis. Vital pulp therapy with calcium-enriched mixture cement (VPT/CEM) as a new alternative treatment option has demonstrated excellent treatment outcomes up to 1 year; if 2-year radiographic/clinical effectiveness as well as cost-effectiveness of the VPT/CEM is also non-inferior compared with RCT, it can serve as a viable treatment for mature molars with irreversible pulpitis. In this prospective, multicenter (n = 23), non-inferiority clinical trial, 407 patients were randomized to either one-visit RCT (n = 202) or VPT/CEM (n = 205) for 27 months. In this part of study, the primary outcome measure was the 2-year clinical and radiographic treatment outcomes. Cost-effectiveness was also analyzed. Mean follow-up times were 24.62 ± 0.72 and 24.61 ± 0.69 months in RCT (n = 166) and VPT/CEM (n = 166) arms, respectively. Clinical success rates in the two study arms were equal (98.19%); however, radiographic success rates were 79.5 and 86.7% in RCT and VPT/CEM arms, respectively, with no statistical difference (P = 0.053). The treatment time span mean was approximately three times greater in the RCT than in the VPT/CEM arm (94.07 vs. 31.09 min; P < 0.001). RCT had a cost of 171.5K per molar tooth compared with 44.5K for VPT. VPT/CEM reduced time and cost spent. When considering clinical as well as cost-effectiveness of VPT/CEM, this treatment option is not only non-inferior but also superior to RCT in mature permanent molar teeth with established irreversible pulpitis. Vital pulp therapy with CEM is a cost-effective and reliable biological technique for endodontic treatment of permanent molar teeth with irreversible pulpitis and can be recommended for general clinical practice.