Double-blind Randomized Placebo-controlled Clinical Trial of Efficiency of Nonsteroidal Anti-inflammatory Drugs in the Control of Post-endodontic Pain

Abstract

Introduction: The present clinical trial aimed to evaluate the efficiency of paracetamol alone and in combination with 3 different nonsteroidal anti-inflammatory drugs for control of post-endodontic pain.

Methods: The inclusion criteria were moderate to severe pain of irreversible pulpitis, by using the Verbal Rating Scale and a 4-10 score on the Numerical Rating Scale, on anterior or premolar teeth, as well as the absence of signs and symptoms of apical periodontitis. One hundred eighty-five trial medications with placebo were prepared, and 170 participants completed the trial. There were 5 groups. P-group received 4 gelatinous capsules of a single dose of paracetamol alone. The IP-group received similar capsules of a single dose of combined ibuprofen/paracetamol. MP-group received combined mefenamic acid/paracetamol, and DP-group received combined diclofenac K/paracetamol. A Plb-group received doubled gelatinous capsules with no medications as a single dose, which had the same weight and appearance as the medicated capsules, to be the placebo.

Results: Pain intensity was measured after initial endodontic therapy and instrumentation by using the Verbal Rating Scale and Numerical Rating Scale. IP-group (ibuprofen/paracetamol) had the most pain reduction, followed by DP-group (combined diclofenac K/paracetamol), then MP-group, followed by P-group, whereas Plb-group had the least pain reduction (P < .05).

Conclusions: The combination of ibuprofen/paracetamol, taken immediately after initial endodontic therapy and root canal preparation in teeth with irreversible pulpitis, reduced post-endodontic pain (ClinicalTrials.gov no.: NCT02417337).

Keywords: Endodontic; Numerical Rating Scale; Verbal Rating Scale; irreversible pulpitis; pain; randomized clinical trial.