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Dexketoprofen Dosage According to Chronotherapy

Primary Purpose

Tooth, Impacted, Trismus, Pain

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexketoprofen 25 MG
Dexketoprofen 25 MG
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted focused on measuring Third, Dexketroprofen, Randomized

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Bilateral impacted lower third molar

Exclusion Criteria:

  • NSAID allergic
  • Contraindication of surgery

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Morning dosage

    Night dosage

    Arm Description

    Dexketoprofen pill at morning; Placebo at night

    Placebo pill at morning; Dexketoprofen at night

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Swelling
    Distance from tragus to pogonion

    Full Information

    First Posted
    December 14, 2021
    Last Updated
    October 10, 2022
    Sponsor
    Universidad Complutense de Madrid
    Collaborators
    McGill University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05176158
    Brief Title
    Dexketoprofen Dosage According to Chronotherapy
    Official Title
    Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    July 1, 2023 (Anticipated)
    Primary Completion Date
    July 1, 2023 (Anticipated)
    Study Completion Date
    November 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Complutense de Madrid
    Collaborators
    McGill University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tooth, Impacted, Trismus, Pain, Inflammatory Response
    Keywords
    Third, Dexketroprofen, Randomized

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantCare ProviderOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Morning dosage
    Arm Type
    Experimental
    Arm Description
    Dexketoprofen pill at morning; Placebo at night
    Arm Title
    Night dosage
    Arm Type
    Experimental
    Arm Description
    Placebo pill at morning; Dexketoprofen at night
    Intervention Type
    Drug
    Intervention Name(s)
    Dexketoprofen 25 MG
    Other Intervention Name(s)
    Morning dosage
    Intervention Description
    Pill at morning
    Intervention Type
    Drug
    Intervention Name(s)
    Dexketoprofen 25 MG
    Other Intervention Name(s)
    Night dosage
    Intervention Description
    Pill at night
    Primary Outcome Measure Information:
    Title
    Post operatory pain
    Description
    Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))
    Time Frame
    From the day of the surgical procedure to the seventh-day
    Secondary Outcome Measure Information:
    Title
    Swelling
    Description
    Distance from tragus to pogonion
    Time Frame
    Baseline and post operatory (day 1, day 3, day 7)
    Other Pre-specified Outcome Measures:
    Title
    Trismus
    Description
    Open mouth limitation in milimiters, interincisal distance
    Time Frame
    Baseline and post operatory (day 1, day 3 and day 7)
    Title
    Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha
    Description
    Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay)
    Time Frame
    Baseline, day 3 and day 7

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Bilateral impacted lower third molar Exclusion Criteria: NSAID allergic Contraindication of surgery
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Fabian Perez-Gonzalez, DDM, MS
    Phone
    670716375
    Email
    fabianpe@ucm.es

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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