Comparison of the Clinical Efficacy of Naproxen, Associated or Not With Esomeprazol, in Lower Third Molar Removal

NCT ID: NCT02494856

Last Updated: 2016-11-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2016-03-31

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.

Conditions

Pain; Other Surgical Procedures; Impacted Third Molar Tooth

Keywords

Naproxen; Lower third molar; Oral Surgery; Esomeprazole

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Surgery with Naproxen

Fifty healthy volunteers underwent removal of symmetrically positioned lower third molars, will be treated to control pain, swelling and trismus with naproxen 500mg.

Group Type: EXPERIMENTAL

Surgery with Naproxen

Intervention Type: DRUG

After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.

Surgery with Naproxen and Esomeprazole

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.

Group Type: EXPERIMENTAL

Surgery with Naproxen and Esomeprazole

Intervention Type: DRUG

After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.

Interventions

Surgery with Naproxen

After lower third molars surgeries, clinical efficacy of the Naproxen 500mg was study.

Intervention Type: DRUG

Surgery with Naproxen and Esomeprazole

After lower third molars surgeries, clinical efficacy of the Naproxen 500mg and Esomeprazole 20mg was study.

Intervention Type: DRUG

Other Intervention Names

Lower third molar surgery with Naproxen; Lower third molar surgery with Naproxen and Esomeprazole

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Giovana Maria Weckwerth

OTHER

Sponsor Role: lead

Responsible Party

Giovana Maria Weckwerth

DDS

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Giovana M Weckwerth, DDS

Role: PRINCIPAL_INVESTIGATOR

416.016.638-54

Locations

University of São Paulo

Bauru, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CAAE: 30317314.4.0000.5417

Identifier Type: -

Identifier Source: org_study_id