Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal
Condition: Pain; Other Surgical Procedures; Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional
Phase: Phase 4

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.
    

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.
    

Intervention name(s): Surgery with Naproxen; Surgery with Naproxen and Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.; After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.
Other intervention name(s): Lower third molar surgery with Naproxen; Lower third molar surgery with Naproxen and Esomeprazole
Intervention MeSH terms: Naproxen; Esomeprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Naproxen; Lower third molar; Oral Surgery; Esomeprazole