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

J Endod. 2016 Jun;42(6):835-42. doi: 10.1016/j.joen.2016.02.014. Epub 2016 Apr 12.


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 ( no.: NCT02417337).

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

Publication types

  • Randomized Controlled Trial

MeSH terms

  • Acetaminophen / therapeutic use
  • Adult
  • Anesthetics, Local / administration & dosage
  • Anti-Inflammatory Agents, Non-Steroidal / therapeutic use*
  • Diclofenac / therapeutic use
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Combinations
  • Female
  • Humans
  • Ibuprofen / therapeutic use
  • Lidocaine / administration & dosage
  • Male
  • Mefenamic Acid / therapeutic use
  • Pain / drug therapy*
  • Pain Measurement / methods*
  • Pain, Postoperative / drug therapy*
  • Pain, Postoperative / prevention & control
  • Placebos / administration & dosage
  • Pulpitis / therapy
  • Root Canal Preparation / adverse effects*
  • Root Canal Preparation / instrumentation
  • Root Canal Preparation / methods
  • Root Canal Therapy / adverse effects
  • Root Canal Therapy / methods


  • Anesthetics, Local
  • Anti-Inflammatory Agents, Non-Steroidal
  • Drug Combinations
  • Placebos
  • Diclofenac
  • Acetaminophen
  • Mefenamic Acid
  • Lidocaine
  • Ibuprofen

Associated data