N Suresh1, V Nagendrababu2,3, V Koteeswaran1, J S Haritha1, S D Swetha1, A Varghese1, V Natanasabapathy1. 1. Faculty of Dentistry, Meenakshi Academy of Higher Education and Research, Meenakshi Ammal Dental College, Chennai, India. 2. Division of Clinical Dentistry, School of Dentistry, International Medical University, Kuala Lumpur, Malaysia. 3. Department of Preventive and Restorative Dentistry, College of Dental Medicine, University of Sharjah, Sharjah, UAE.
Abstract
AIM: 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. METHODOLOGY: 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 20 mg piroxicam, 20 mg prednisolone, 4 mg dexamethasone or a placebo 60 min before root canal treatment. Patients recorded their postoperative pain intensity at 6, 12, 24, 48 and 72 h 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. RESULTS: 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 6 h (P = 0.009), 12 h (P = 0.003) and 24 h (P = 0.008). Mean intensity of pain was significantly more intense at 6, 12 and 24 h 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. CONCLUSION: Preoperative oral administration of a single dose of 4 mg dexamethasone, 20 mg piroxicam or 20 mg 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 24 h. The odds of postoperative pain at 24 h for patients premedicated with 4 mg dexamethasone or 20 mg piroxicam or 20 mg prednisolone were 5.3 times, 3.4 times and 2.5 times less compared to the placebo, respectively.
RCT Entities:
AIM: 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. METHODOLOGY: 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 20 mg piroxicam, 20 mg prednisolone, 4 mg dexamethasone or a placebo 60 min before root canal treatment. Patients recorded their postoperative pain intensity at 6, 12, 24, 48 and 72 h 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. RESULTS: 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 6 h (P = 0.009), 12 h (P = 0.003) and 24 h (P = 0.008). Mean intensity of pain was significantly more intense at 6, 12 and 24 h 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. CONCLUSION: Preoperative oral administration of a single dose of 4 mg dexamethasone, 20 mg piroxicam or 20 mg 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 24 h. The odds of postoperative pain at 24 h for patients premedicated with 4 mg dexamethasone or 20 mg piroxicam or 20 mg prednisolone were 5.3 times, 3.4 times and 2.5 times less compared to the placebo, respectively.