Abstract

This randomized, double-blinded, clinical trial evaluated the effect of oral premedication of piroxicam, prednisolone, dexamethasone or placebo on postoperative pain after single-visit root canal treatment in teeth with symptomatic irreversible pulpitis and symptomatic apical periodontitis. The trial is reported according to the Preferred Reporting Items for RAndomized Trials in Endodontics (PRIRATE) 2020 guidelines. The protocol was registered at the clinical trial registry (India) (CTRI/2019/06/019818). In total, 160 patients, assigned to four groups, received orally either 20mg piroxicam, 20mg prednisolone, 4mg dexamethasone or a placebo 60min before root canal treatment. Patients recorded their postoperative pain intensity at 6, 12, 24, 48 and 72h using a 10-cm visual analogue scale. Intergroup comparison was performed using Kruskal-Wallis tests with post hoc analysis using Dunns test. Incidence of pain was analysed using chi-square tests. A P value<0.05 was considered to be statistically significant. Binary logistic regression was used to determine the odds of postoperative pain, with incidence of pain as the dependent variable and intervention groups, gender, age and type of tooth as independent variables. In total, 156 patients were analysed in the trial, since four patients dropped out during follow-up. All drugs were associated with a significantly lower incidence of postoperative pain compared to the placebo at 6h (P=0.009), 12h (P=0.003) and 24h (P=0.008). Mean intensity of pain was significantly more intense at 6, 12 and 24h with the use of placebo in comparison to the other three intervention groups (P<0.05). Intensity of pain was not significantly different between the premedications used (P>0.05). One patient in the piroxicam group reported gastritis, whereas no adverse effects were recorded in other groups. Preoperative oral administration of a single dose of 4mg dexamethasone, 20mg piroxicam or 20mg prednisolone reduced the incidence and severity of postoperative pain following single-visit root canal treatment compared to a placebo in patients with symptomatic irreversible pulpitis and symptomatic apical periodontitis up to 24h. The odds of postoperative pain at 24h for patients premedicated with 4mg dexamethasone or 20mg piroxicam or 20mg prednisolone were 5.3 times, 3.4 times and 2.5 times less compared to the placebo, respectively.

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