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NCT05176158 Clinical Trial

Dexketoprofen Dosage According to Chronotherapy

Pain Clinical Trial

Official title:
Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT05176158
Other study ID # 2019-000736-26
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2023
Est. completion date November 1, 2023

Study information
Verified date October 2022
Source Universidad Complutense de Madrid
Contact Fabian Perez-Gonzalez, DDM, MS
Phone 670716375
Email fabianpe@ucm.es
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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

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.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 10
Est. completion date November 1, 2023
Est. primary completion date July 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Bilateral impacted lower third molar Exclusion Criteria: - NSAID allergic - Contraindication of surgery

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexketoprofen 25 MG
Pill at morning
• Dexketoprofen 25 MG
Pill at night

Locations
Country Name City State
n/a

Sponsors (2)
Lead Sponsor Collaborator
Universidad Complutense de Madrid McGill University

Outcome
Type Measure Description Time frame Safety issue
Other Trismus Open mouth limitation in milimiters, interincisal distance Baseline and post operatory (day 1, day 3 and day 7)
Other Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay) Baseline, day 3 and day 7
Primary Post operatory pain 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 Swelling Distance from tragus to pogonion Baseline and post operatory (day 1, day 3, day 7)
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