Clinical trial NCT02494856: Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Other Surgical Procedures
Impacted Third Molar Tooth
Keywords: Naproxen
Lower third molar
Oral Surgery
Esomeprazole
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2015-07-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Eligibility 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.

Primary outcomes:
measure: Evaluation of postsurgical pain
timeFrame: Seventh postoperative day
measure: Quality of anesthesia
timeFrame: During the surgical procedure
measure: Intraoperative bleeding
timeFrame: During the surgical procedure
measure: Blood pressure
timeFrame: During the surgical procedure
measure: Heart rate
timeFrame: During the surgical procedure
measure: Oxygen saturation
timeFrame: During the surgical procedure
Secondary outcomes:
measure: Postoperative mouth opening
timeFrame: Second and Seventh postoperative days
measure: Onset and duration of surgery after administration of anesthetic
timeFrame: During the surgery
measure: Incidence, type and severity of adverse reactions
timeFrame: Seventh postoperative day
measure: Total amount of rescue medication
timeFrame: Seventh postoperative day
measure: Measurement the facial edema
timeFrame: On the second day after surgery and on the seventh day after surgery.
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: University of São Paulo
state: SP
Study officials:
affiliation: 416.016.638-54
name: Giovana M Weckwerth, DDS
role: PRINCIPAL_INVESTIGATOR
References: