Short-Term Outcomes of Full Pulpotomy Compared With Root Canal Treatment for Irreversible Pulpitis: The PROVE Study

Objectives: To assimilate data from individual randomised trials and perform a pooled analysis of short-term outcomes of pulpotomy compared with root canal treatment (RCT) for teeth with symptomatic irreversible pulpitis (SIRP). Methods: Randomised trials were conducted in eight countries using a standardised clinical protocol and outcome measures. Inclusion criteria were a diagnosis of SIRP in a restorable tooth that could be adequately isolated. A block randomisation method was used. Short-term outcomes were postoperative pain (assessed at baseline, day 3 and day 7), analgesic consumption and early failure, which was defined as the need for additional intervention within 4 weeks of treatment. Data were analysed using R v4.3.1. Results: A total of 410 patients were randomised, with data available for 385 patients. A significant reduction in pain intensity was observed over time for each treatment group (p < 0.0001). Participants who received RCT were observed to have a significantly greater decrease in pain intensity between baseline and day 3, mean Numeric Rating Scale (NRS-11) of 1.7 (p = 0.0034) and from day 3 to day 7 with a mean NRS of 0.7 (p = 0.0471) compared with participants treated with pulpotomy who had mean NRS of 2.4 and 1.2 respectively. Use of analgesics remained high between baseline and day 3 for participants treated with pulpotomy but significantly decreased for RCT (51.1%, 70/137 vs. 33.3%, 46/138; p = 0.0042). The use of analgesics was significantly reduced in both treatment groups between day 3 and day 7 but was significantly higher at day 7 for participants treated with pulpotomy compared to RCT (19.7%, 27/137 vs. 9.4%, 13/138; p = 0.0246). Early failure was significantly more common for participants who underwent pulpotomy treatment (10/192; 5.2%) compared with RCT (1/193; 0.5%) (p = 0.0141) and was associated with preoperative tenderness to percussion (TTP), molar teeth, sleep disturbance and prolonged bleeding time after exposure. Conclusion: The PROVE study provides the first robust evidence that both pulpotomy and RCT provided effective pain relief up to day 7; but significantly more pain relief and reduced analgesic intake were evident after RCT. Early failure rate was low in both groups.