EVALUATION OF THE EFFECTIVENESS OF PRE-emptive ANALGESIA BYADMINISTRATION OF IBUPROFEN 400MG, FOR THE CONTROL OFPOSTOPERATIVE ACUTE PAIN in the extraction of IMPACTED THIRD MOLARMANDIBULAR

Phase 1

• Conditions: POST-OPERATIVE ACUTE PAIN (DAPO); MedDRA version: 17.1Level: PTClassification code 10031009Term: Oral painSystem Organ Class: 10017947 - Gastrointestinal disorders; MedDRA version: 17.1Level: PTClassification code 10030973Term: Oral discomfortSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2013-003323-11-IT
• Lead Sponsor: Sapienza University of Rome

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02-04
• Last Update Posted: 5 March 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

males and females aged between 18 and 40 years, absence of systemic
disease (ASA class I), non-smoking or smoking <10 cigarettes / day;
plaque index and bleeding less than 25%, indicating to extract both
lower wisdom teeth inclusion in partial or total bilateral bone
(osteotomy applicant), similar in depth, inclination and position, no
medication in the 10 days prior to the extraction, presence in the arch of
the first and second molars, absence of pain and associated osteolytic
disease.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 21
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria will be: persons under age or older than 40 years old; subjects with systemic diseases; Smoking <10 cigarettes / day; plaque index and bleeding than 25%; individuals with anatomical differences between the lower wisdom teeth inclusion in partial or total bilateral bone (osteotomy applicant), with respect to the depth, the 'tilt and position; subjects who took drugs in the 10 days prior to extraction; absence in the arch of the first and second molar; the presence of lytic bone disease and pain symptoms associated with items to be extracted.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified