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Dexketoprofen Dosage According to Chronotherapy

Sponsor
Universidad Complutense de Madrid (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05176158
Collaborator
McGill University (Other)
10
Enrollment
2
Arms
4
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

Lower third molar extraction is one of the most common treatments in oral surgery practice. It is a treatment with inherent complications such as postoperative pain, swelling or trismus. In order to minimize disconfort after extraction, analgesic and anti-inflammatory medication is prescribed. Recently, it is seen that circadian rhythm may play an important role on drugs metabolism, modulating its effect depending on the moment of administration.

The aim of the study is to analyze if dosage modification of a Non Steroideal Anti-Inflammatory (dexketoprofen) affects on postoperative pain, swelling and open mouth limitation according the circadian clock

Condition or Disease Intervention/Treatment Phase
  • Drug: Dexketoprofen 25 MG
  • Drug: Dexketoprofen 25 MG
 N/A

Detailed Description

A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed randomly in one side intake morning medication dosage while the contralateral side will be prescribed a night dosage. Moreover, a blood sample will be obtained to analyze the inflammatory profile.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
Anticipated Study Start Date :
Jul 1, 2022
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Nov 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Morning dosage

Dexketoprofen pill at morning; Placebo at night

Drug: Dexketoprofen 25 MG
Pill at morning
Other Names:
  • Morning dosage

    		•
    Experimental: Night dosage

    Placebo pill at morning; Dexketoprofen at night

    Drug: Dexketoprofen 25 MG
    Pill at night
    Other Names:
  • Night dosage

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Post operatory pain [From the day of the surgical procedure to the seventh-day]

      Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))

    Secondary Outcome Measures

    1. Swelling [Baseline and post operatory (day 1, day 3, day 7)]

      Distance from tragus to pogonion

    Other Outcome Measures

    1. Trismus [Baseline and post operatory (day 1, day 3 and day 7)]

      Open mouth limitation in milimiters, interincisal distance

    2. Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha [Baseline, day 3 and day 7]

      Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 35 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Bilateral impacted lower third molar
    Exclusion Criteria:

    • NSAID allergic

    • Contraindication of surgery

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Universidad Complutense de Madrid
    • McGill University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jesús Torres García Denche, Associate professor, Universidad Complutense de Madrid
    ClinicalTrials.gov Identifier:
    NCT05176158
    Other Study ID Numbers:
    • 2019-000736-26
    First Posted:
    Jan 4, 2022
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jesús Torres García Denche, Associate professor, Universidad Complutense de Madrid
    Third
    Dexketroprofen
    Randomized
    Additional relevant MeSH terms:
    Tooth, Impacted
    Trismus
    Dexketoprofen trometamol

    Study Results

    No Results Posted as of May 18, 2022