Dexketoprofen Dosage According to Chronotherapy

November 30, 2024 updated by: Jesús Torres García Denche, Universidad Complutense de Madrid

Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Madrid, Spain, 28040
        • UCM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Bilateral impacted lower third molar

Exclusion Criteria:

  • NSAID allergic
  • Contraindication of surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Morning dosage
Dexketoprofen pill at morning; Placebo at night
Drug: Dexketoprofen 25 MG
Pill at morning
Other Names:
  • Morning dosage
Drug: Dexketoprofen 25 MG
Pill at night
Other Names:
  • Night dosage
Experimental: Night dosage
Placebo pill at morning; Dexketoprofen at night
Drug: Dexketoprofen 25 MG
Pill at morning
Other Names:
  • Morning dosage
Drug: Dexketoprofen 25 MG
Pill at night
Other Names:
  • Night dosage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Post operatory pain
Time Frame: 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))
From the day of the surgical procedure to the seventh-day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Swelling
Time Frame: Baseline and post operatory (day 1, day 3, day 7)
Distance from tragus to pogonion
Baseline and post operatory (day 1, day 3, day 7)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trismus
Time Frame: Baseline and post operatory (day 1, day 3 and day 7)
Open mouth limitation in milimiters, interincisal distance
Baseline and post operatory (day 1, day 3 and day 7)
Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha
Time Frame: Baseline, day 3 and day 7
Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay)
Baseline, day 3 and day 7

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad Complutense de Madrid

Collaborators

McGill University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Actual)

November 1, 2024

Study Completion (Actual)

November 1, 2024

Study Registration Dates

First Submitted

December 14, 2021

First Submitted That Met QC Criteria

January 3, 2022

First Posted (Actual)

January 4, 2022

Study Record Updates

Last Update Posted (Actual)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 30, 2024

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-000736-26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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