Comparison of the Clinical Efficacy of Ketoprofen, Associated or Not With Omeprazole in Lower Third Molar Removal
Status:
Completed
Trial end date:
2017-03-01
Target enrollment:
Participant gender:
Summary
The control of pain, swelling and trismus in patients undergoing oral and maxillofacial
surgery is frequently performed through the administration of non-steroidal anti-inflammatory
drugs (NSAIDS). The present study aims to evaluate in a double blind, randomized and
crossover manner the clinical efficacy of ketoprofen (immediate release - 100 mg) and
ketoprofen in association with omeprazole (modified release - 200 mg ketoprofen with 20 mg
omeprazole) in 50 patients aged 18 years or older that require removal of both lower third
molars symmetrically positioned. After collection, data will be analyzed by means of graphs
and tables to allow the appropriate analyses. Paired t-test will be used to compare the
duration of surgeries. Nonparametric Wilcoxon test will be used for the analysis of "rescue
medication" and postoperative pain parameters (visual analog scale). Data of "mouth opening"
and "swelling" will be statistically analyzed through analysis of variance (ANOVA) followed
by Tukey's test for multiple comparisons. Statistical significance will be set at 5%. Results
will be presented as mean ± standard deviation of the mean.
Phase:
Phase 4
Details
Lead Sponsor:
Luis Fernando Simoneti
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo