MedPath

Efficacy of a decrease of Ibuprofen dosage in wisdom teeth extraction.

Phase 1
Conditions
The clinical trial will try to understand if the elimination of the ibuprofen dosage in resting phase after surgical third molar extraction not jeopardize the postoperative period .
Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]
Registration Number
EUCTR2019-000736-25-ES
Lead Sponsor
niversidad Complutense de Madrid
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Authorised-recruitment may be ongoing or finished
Sex
Not specified
Target Recruitment
60
Inclusion Criteria

(i) be aged between 18- 35-year-old, (ii) be healthy according to the American Society of Anaesthesiologists (ASA) classification (subject should not have an active infection, trismus hyperthermia, and swelling before surgery and can maintain adequate oral hygiene), (iii) capable to fill out a questionnaire, (iv) be capable to sign an informed consent form. In addition, to standardize the clinical case of the third molar surgical extraction, the indicated teeth should be lower third molar and completely impacted.
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 60
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 0

Exclusion Criteria

(i) have a history of systemic diseases (e.g., diabetes mellitus, hypertension, gastric ulcer), (ii) have a severe/serious illness that requires frequent hospitalization, (iii) are smokers, (iv) are pregnant or breast feeding, (v) are taking any medications or are allergic to NSAIDs, (vi) have impaired cognitive or motor function, (vii) are unable to return for evaluations/study recalls.

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath