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

Efficacy of Non-Steroidal Anti-Inflammatory (Ibuprofen) Chronotherapy in Healing After Mandibular Third Molar Surgical Extraction – A Randomized Clinical Trial - Efficacy of NSAIDs dosage in wisdom teeth extraction.

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-000736-25-ES

Enrollment

Registered

2019-04-30

Start date

2019-09-05

Completion date

Unknown

Last updated

2019-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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 .

Interventions

Trade Name: Ibufen 400 Product Name: Ibuprofen 400 Product Code: M01AE01 Pharmaceutical Form: Capsule INN or Proposed INN: DEXIBUPROFEN

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate pain, trismus, swelling and inflamatory citokines after surgical third molar extraction;Secondary Objective: Not applicable;Primary end point(s): The decrease of pain, trismus and swelling levels compared to normal ibuprofen doses.;Timepoint(s) of evaluation of this end point: 7 days after extraction	—

Secondary

Measure	Time frame
Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable	—

Countries

Spain

Contacts

Public ContactMaster de Cirugia Bucal

Universidad Complutense de Madrid

jesus.torres@ucm.es

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026