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

NCT02494856 | Completed Phase 4 DMC

• 1 other identifier: CAAE: 30317314.4.0000.5417
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Other Surgical Procedures; Impacted Third Molar Tooth

Keywords

Naproxen; Lower third molar; Oral Surgery; Esomeprazole

Outcome Measures

Primary Outcomes (6)

• Evaluation of postsurgical pain

  Subjective evaluation of postsurgical pain, which was annotated by the volunteer, a Visual Analogue Scale (VAS, 0-100 mm) and total amount (mg) of rescue medication consumption in the postoperative period. The subjective pain evaluations will be performed by patients at the following times after administration of the drugs \[0, 15, 30 and 45 min, 1; 1.5; 2; 3; 4; 5; 6; 7; 8; 10; 12; 16; 24 hr, 48, 72 and 96 h\].

  Seventh postoperative day

• Quality of anesthesia

  Quality of anesthesia during surgery based on a category 3point scale: 1) the patient reported no discomfort; 2) the patient reported discomfort, without the need to supplement the anesthesia; 3) reported some discomfort by the patient, requiring anesthesia complementation. Intraoral bleeding that will be evaluated by the surgeon according to a 3point scale (1: minimal, 2: normal and 3: Maximum), immediately after the following steps: injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing.

  During the surgical procedure

• Intraoperative bleeding

  Intraoperative bleeding, rated by the surgeon according to a 3 point category rating scale (1 minimal bleeding; 2 normal bleeding; 3 excessive bleeding) (SISK, 1986), immediately after the following steps: injection of the first cartridge of articaine, tissue incision, flap reflection, bone removal (when this procedure was necessary), tooth extraction, cleaning of the operated site, and completion of suturing.

  During the surgical procedure

• Blood pressure

  Systolic blood pressure, diastolic, and mean to be verified and recorded at surgical moments previously described (injection of the first cartridge anesthesia, incision, mucoperiosteal detachment, osteotomies, tooth section, extraction, cleaning and suturing), carried out with the aid of a system for monitoring hemodynamic parameters.

  During the surgical procedure

• Heart rate

  Heart rate to be verified and recorded surgical at moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

  During the surgical procedure

• Oxygen saturation

  Oxygen saturation to be verified and recorded at surgical moments described above, carried out with the aid of a system for monitoring hemodynamic parameters.

  During the surgical procedure

Secondary Outcomes (5)

• Postoperative mouth opening

  Second and Seventh postoperative days

• Onset and duration of surgery after administration of anesthetic

  During the surgery

• Incidence, type and severity of adverse reactions

  Seventh postoperative day

• Total amount of rescue medication

  Seventh postoperative day

• Measurement the facial edema

  On the second day after surgery and on the seventh day after surgery.

Study Arms (2)

Surgery with Naproxen

EXPERIMENTAL

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

Drug: Surgery with Naproxen

Surgery with Naproxen and Esomeprazole

EXPERIMENTAL

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.

Drug: Surgery with Naproxen and Esomeprazole

Interventions

Surgery with Naproxen DRUG

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

Also known as: Lower third molar surgery with Naproxen

Surgery with Naproxen

Surgery with Naproxen and Esomeprazole DRUG

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

Also known as: Lower third molar surgery with Naproxen and Esomeprazole

Surgery with Naproxen and Esomeprazole

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Need of lower third molar surgeries in similar positions

You may not qualify if:

• 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.

Sponsors & Collaborators

• Giovana Maria Weckwerth: lead
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

University of São Paulo

Bauru, São Paulo, 17012-901, Brazil

Location

MeSH Terms

Conditions

Pain

Interventions

Surgical Procedures, Operative; Naproxen; Esomeprazole

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Naphthaleneacetic Acids; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Giovana M Weckwerth, DDS

  416.016.638-54

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: DDS

Study Record Dates

• First Submitted: July 7, 2015
• First Posted: July 10, 2015
• Study Start: October 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: March 1, 2016
• Last Updated: November 4, 2016

Record last verified: 2016-11

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)