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OpenTrials
Completed

NCT Number: NCT05176158

Dexketoprofen Dosage According to Chronotherapy

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

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Key information

Conditions

Tooth, Impacted Inflammatory Response Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Stomatognathic Diseases Tooth Diseases Trismus

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UCM

Madrid, 28040, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Bilateral impacted lower third molar

Exclusion criteria

  • NSAID allergic
  • Contraindication of surgery

Treatment and study plan

Dexketoprofen 25 MG

Drug

Pill at morning

Other names: Morning dosage

Primary outcomes

  1. 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))

Secondary outcomes

  1. Swelling

    Time frame: Baseline and post operatory (day 1, day 3, day 7)

    Distance from tragus to pogonion

Other outcomes

  1. Trismus

    Time frame: 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

    Time frame: Baseline, day 3 and day 7

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

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • McGill University

Registry information

Official study title

Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 4, 2022
Registry last updated
Dec 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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