Objectives: The aim of this study was to evaluate the efficacy of Lornoxicam versus a commonly used anti-inflammatory drug (Flurbiprofen) and a placebo in the management of the postoperative discomfort after the surgical removal of mandibular third molars. The null hypothesis was that there would be no difference between the three protocols analysed. Materials and Methods: Ninety-one patients who needed surgical extraction of an impacted mandibular third molar were selected for the study. The study was performed according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The sample size calculation was performed taking into account the identification of the three groups, with an effect size of 0.40, alpha= 0.050, and with a power level of 0.80 for pain, which represented the primary variable selected for the analysis. The primary variable ‘pain’ presented a difference between groups of 0.62 (mean) and a standard deviation (SD) of 0.73. The assignment of each patient to a study group was determined by means of a randomization technique using sealed and numbered envelopes; details of the sequence were concealed. An operator not involved in the subsequent experimentation generated a random allocation sequence, in a 1:1:1 ratio, for the distribution of the patients to one of the three study groups, performed with a permuted block design using a computer generator. All subjects were randomly allocated to receive one of the following treatments twice a day for 5 days after surgery: placebo (n = 29), Flurbiprofen (n = 31), or Lornoxicam (n = 31). The primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at 30 min, 2, 6, 12, 24, 48 h, 7 and 10 days following surgery. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones (obtained at each follow-up session, i.e. at 24, 72 h, 5, 7 and 10 days) of the different facial measurements. The Kruskal–Wallis test was applied to compare pain scores, facial distances, and maximum mouth opening among the three groups at each observation time point. The Mann–Whitney test was applied for two-by-two comparisons. The Friedman test was applied for the comparison of the measurements at the different observation time points within each group. The Wilcoxon test was used to perform two-by-two comparisons between time observations, for each follow-up session. For each treatment, the area under the curve (AUC) was calculated with a relative 95% confidence interval (CI) and significance. The significance of the P-value was set at 0.05. Results: Compared to placebo, treatment with Flurbiprofen and Lornoxicam was characterised by an improvement in the primary outcome. Moreover, the treatment with Lornoxicam presented significantly lower median pain scores at 2h (p<0.001) and at 6h (p=0.016) compared to Flurbiprofen and at 2h (p<0.001), 6h (p=0.01), and at 24h (p=0.018) after surgery compared with placebo. Swelling and maximum mouth opening values were not significantly different between the groups at each follow-up session. Regarding the AUC, for the placebo, an AUC=0.475, p=0.208 and for Flurbiprofen an AUC=0.501, p=0.937 was obtained, which were not significant; for Lornoxicam, a higher AUC=0.614 with a p-value<0.001. Conclusions: This trial demonstrated that treatment with Lornoxicam showed a decrease in the incidence and severity of pain in the first postoperative phase following third molar surgery compared to Flurbiprofen and placebo.

Evaluation of the Efficacy of Lornoxicam and Flurbiprofen on Postsurgical Management of Pain and Perioperative Sequelae Following Third Molar Surgery: A Randomized, Controlled, Clinical Trial.

Sebastiano Ferlito;Gaetano Isola
Ultimo
Writing – Review & Editing
2020

Abstract

Objectives: The aim of this study was to evaluate the efficacy of Lornoxicam versus a commonly used anti-inflammatory drug (Flurbiprofen) and a placebo in the management of the postoperative discomfort after the surgical removal of mandibular third molars. The null hypothesis was that there would be no difference between the three protocols analysed. Materials and Methods: Ninety-one patients who needed surgical extraction of an impacted mandibular third molar were selected for the study. The study was performed according to the CONSORT (Consolidated Standards of Reporting Trials) guidelines. The sample size calculation was performed taking into account the identification of the three groups, with an effect size of 0.40, alpha= 0.050, and with a power level of 0.80 for pain, which represented the primary variable selected for the analysis. The primary variable ‘pain’ presented a difference between groups of 0.62 (mean) and a standard deviation (SD) of 0.73. The assignment of each patient to a study group was determined by means of a randomization technique using sealed and numbered envelopes; details of the sequence were concealed. An operator not involved in the subsequent experimentation generated a random allocation sequence, in a 1:1:1 ratio, for the distribution of the patients to one of the three study groups, performed with a permuted block design using a computer generator. All subjects were randomly allocated to receive one of the following treatments twice a day for 5 days after surgery: placebo (n = 29), Flurbiprofen (n = 31), or Lornoxicam (n = 31). The primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at 30 min, 2, 6, 12, 24, 48 h, 7 and 10 days following surgery. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones (obtained at each follow-up session, i.e. at 24, 72 h, 5, 7 and 10 days) of the different facial measurements. The Kruskal–Wallis test was applied to compare pain scores, facial distances, and maximum mouth opening among the three groups at each observation time point. The Mann–Whitney test was applied for two-by-two comparisons. The Friedman test was applied for the comparison of the measurements at the different observation time points within each group. The Wilcoxon test was used to perform two-by-two comparisons between time observations, for each follow-up session. For each treatment, the area under the curve (AUC) was calculated with a relative 95% confidence interval (CI) and significance. The significance of the P-value was set at 0.05. Results: Compared to placebo, treatment with Flurbiprofen and Lornoxicam was characterised by an improvement in the primary outcome. Moreover, the treatment with Lornoxicam presented significantly lower median pain scores at 2h (p<0.001) and at 6h (p=0.016) compared to Flurbiprofen and at 2h (p<0.001), 6h (p=0.01), and at 24h (p=0.018) after surgery compared with placebo. Swelling and maximum mouth opening values were not significantly different between the groups at each follow-up session. Regarding the AUC, for the placebo, an AUC=0.475, p=0.208 and for Flurbiprofen an AUC=0.501, p=0.937 was obtained, which were not significant; for Lornoxicam, a higher AUC=0.614 with a p-value<0.001. Conclusions: This trial demonstrated that treatment with Lornoxicam showed a decrease in the incidence and severity of pain in the first postoperative phase following third molar surgery compared to Flurbiprofen and placebo.
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/20.500.11769/370300
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