Overview

This trial has been completed.

Conditions pain, other surgical procedures, impacted third molar tooth
Treatments surgery with naproxen, surgery with naproxen and esomeprazole
Phase phase 4
Sponsor Giovana Maria Weckwerth
Collaborator Fundação de Amparo à Pesquisa do Estado de São Paulo
Start date October 2014
End date December 2015
Trial size 50 participants
Trial identifier NCT02494856, CAAE: 30317314.4.0000.5417

Summary

The present clinical trial randomized compared the clinical efficacy of the naproxen associated or not with esomeprazol, for the removal of lower third molars. Onset, duration of postoperative analgesia, duration of anesthetic action on soft tissues, intraoperative bleeding, hemodynamic parameters, postoperative mouth opening and wound healing at the 7th postoperative day were evaluated. For this purpose, 50 healthy volunteers underwent removal of symmetrically positioned lower third molars, in two separate appointments (one to two months apart), under local anesthesia with either articaine 4% (1:200,000 adrenaline) in a doubleblind, randomized and crossed manner.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose supportive care
Arm
(Experimental)
Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg.
surgery with naproxen Lower third molar surgery with Naproxen
After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.
(Experimental)
Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg and esomeprazole 20mg.
surgery with naproxen and esomeprazole Lower third molar surgery with Naproxen and Esomeprazole
After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.

Primary Outcomes

Measure
Evaluation of postsurgical pain
time frame: Seventh postoperative day
Quality of anesthesia
time frame: During the surgical procedure
Intraoperative bleeding
time frame: During the surgical procedure
Blood pressure
time frame: During the surgical procedure
Heart rate
time frame: During the surgical procedure
Oxygen saturation
time frame: During the surgical procedure

Secondary Outcomes

Measure
Postoperative mouth opening
time frame: Second and Seventh postoperative days
Onset and duration of surgery after administration of anesthetic
time frame: During the surgery
Incidence, type and severity of adverse reactions
time frame: Seventh postoperative day
Total amount of rescue medication
time frame: Seventh postoperative day
Measurement the facial edema
time frame: On the second day after surgery and on the seventh day after surgery.

Eligibility Criteria

Male or female participants from 18 years up to 50 years old.

Inclusion Criteria: - Need of lower third molar surgeries in similar positions Exclusion Criteria: - Presence of systemic diseases; - Presence of local inflammation and/or infection; - Any history of allergic reaction to local anesthetics, gastrointestinal bleeding or ulceration; - Cardiovascular, kidney or hepatic diseases; - Patients who are making use of antidepressants, diuretics or anticoagulants; - Asthma and allergy to aspirin, naproxen or any other nonsteroidal antiinflammatory drug; - Regular use of any nonsteroidal antiinflammatory drug, - pregnancy or - breast feeding.

Additional Information

Official title Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in the Control of Pain, Swelling and Trismus in Lower Third Molar Removal
Principal investigator Giovana M Weckwerth, DDS
Description The control of pain, swelling and trismus in patients undergoing oral and maxillofacial surgery is frequently performed through the administration of non-steroidal antiinflammatory 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 cross over manner the clinical efficacy of naproxen (500 mg) and naproxen in association with esomeprazol (500 mg and 20 mg), both administered by oral route every 12 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). The comparative analyses of the data along with the application of the adequate statistical tests will provide the basis for an evaluation of the clinical efficacy of both NSAIDS.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by University of Sao Paulo.