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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 pain

Quality of anesthesia

Intraoperative bleeding

Blood pressure

Heart rate

Oxygen saturation

Secondary outcome:

Postoperative mouth opening

Onset 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

Page last updated: August 23, 2015

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