Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal
Information source: University of Sao Paulo
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain; Other Surgical Procedures; Impacted Third Molar Tooth
Intervention: Surgery with Naproxen (Drug); Surgery with Naproxen and Esomeprazole (Drug)
Phase: Phase 4
Status: Recruiting
Sponsored by: Giovana Maria Weckwerth Official(s) and/or principal investigator(s): Giovana M Weckwerth, DDS, Principal Investigator, Affiliation: 416.016.638-54
Overall contact: Giovana M Weckwerth, DDS, Phone: (14) 9782-7828, Email: giovana.weck@hotmail.com
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.
Clinical Details
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
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Evaluation of postsurgical painQuality of anesthesia Intraoperative bleeding Blood pressure Heart rate Oxygen saturation
Secondary outcome: Postoperative mouth openingOnset and duration of surgery after administration of anesthetic Incidence, type and severity of adverse reactions Total amount of rescue medication Measurement the facial edema
Detailed 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.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Giovana M Weckwerth, DDS, Phone: (14) 9782-7828, Email: giovana.weck@hotmail.com
University of São Paulo, Bauru, SP 17012-901, Brazil; Recruiting Giovana M Weckwerth, DDS, Phone: (14) 9782-7828, Email: giovana.weck@hotmail.com
Additional Information
Starting date: October 2014
Last updated: July 9, 2015
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