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Dexketoprofen Dosage According to Chronotherapy

NCT ID: NCT05176158

Last Updated: 2024-12-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-01

Study Completion Date

2024-11-01

Brief Summary

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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

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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.

Conditions

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Tooth, Impacted Trismus Pain Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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Morning dosage

Dexketoprofen pill at morning; Placebo at night

Group Type EXPERIMENTAL

Dexketoprofen 25 MG

Intervention Type DRUG

Pill at morning

Night dosage

Placebo pill at morning; Dexketoprofen at night

Group Type EXPERIMENTAL

Dexketoprofen 25 MG

Intervention Type DRUG

Pill at night

Interventions

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Dexketoprofen 25 MG

Pill at morning

Intervention Type DRUG

Dexketoprofen 25 MG

Pill at night

Intervention Type DRUG

Other Intervention Names

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Morning dosage Night dosage

Eligibility Criteria

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Inclusion Criteria

* Bilateral impacted lower third molar

Exclusion Criteria

* NSAID allergic
* Contraindication of surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jesús Torres García Denche

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UCM

Madrid, , Spain

Site Status

Countries

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Spain

Other Identifiers

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2019-000736-26

Identifier Type: -

Identifier Source: org_study_id