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Comparison of the clinical efficacy of ketoprofen, associated or not with omeprazole, in the control of pain, swelling and trismus in lower third molar removal

Grant number: 14/25792-0
Support Opportunities:Scholarships in Brazil - Master
Effective date (Start): May 01, 2015
Effective date (End): February 28, 2017
Field of knowledge:Biological Sciences - Pharmacology - Clinical Pharmacology
Acordo de Cooperação: Coordination of Improvement of Higher Education Personnel (CAPES)
Principal Investigator:Carlos Ferreira dos Santos
Grantee:Luis Fernando Simoneti
Host Institution: Faculdade de Odontologia de Bauru (FOB). Universidade de São Paulo (USP). Bauru , SP, Brazil


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). Studies have shown that NSAIDS exert their therapeutic effect by the inhibition of cyclooxigenases (COX) 1 and 2, which determines the inhibition of prostaglandins production whose effects potentiate the action of many inflammatory mediators. The present study aims to evaluate in a double blind, randomized and crossover manner the clinical efficacy of ketoprofen (200 mg) and ketoprofen in association with omeprazole (200 mg and 20 mg, respectively), both administered by oral route every 24 h during 4 days, in 50 patients aged 18 years or older that require removal of both lower third molars symmetrically positioned. The following parameters will be analyzed: 1) subjective postoperative pain evaluation, with the aid of a visual analogue scale; 2) mouth opening before the surgery, on the 2nd and 7th postoperative days (moment of suture removal); 3) beginning and duration of the surgery after anesthetic administration; 4) incidence, type and severity of adverse reactions; 5) total amount of rescue analgesic medication (paracetamol); 6) facial swelling measured on the 2nd and 7th postoperative days (in comparison with the measurements before the surgery). 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. (AU)

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Scientific publications
(References retrieved automatically from Web of Science and SciELO through information on FAPESP grants and their corresponding numbers as mentioned in the publications by the authors)
LUIS FERNANDO SIMONETI; GIOVANA MARIA WECKWERTH; THIAGO JOSÉ DIONÍSIO; ELZA ARAUJO TORRES; PAULO ZUPELARI-GONÇALVES; ADRIANA MARIA CALVO; JOSÉ ROBERTO LAURIS; FLÁVIO CARDOSO FARIA; CARLOS FERREIRA SANTOS. Efficacy of Ketoprofen With or Without Omeprazole for Pain And Inflammation Control After Third Molar Removal. Brazilian Dental Journal, v. 29, n. 2, p. 140-149, . (14/25792-0)
Academic Publications
(References retrieved automatically from State of São Paulo Research Institutions)
SIMONETI, Luis Fernando. Comparison of the clinical efficacy of ketoprofen, associated or not with omeprazole, in the control of pain, swelling and trismus in lower third molar removal. 2017. Master's Dissertation - Universidade de São Paulo (USP). Faculdade de Odontologia de Bauru (FOB/SDB) Bauru.

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