An interventional study of Dexketoprofen 25 MG and Dexketoprofen 25 MG in Tooth, Impacted, Trismus and Pain, sponsored by Universidad Complutense de Madrid. Completed at 1 site in Spain. Open to participants aged 18 Years to 35 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-04.
Sponsored by Universidad Complutense de Madrid · Not applicable, Interventional, and Treatment
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
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.
122 studies on the registry are indexed under Tooth, Impacted; 15 are open to participants now.
This study's enrollment of 10 is below the median of 70 across 88 interventional studies indexed under Tooth, Impacted.
Browse Tooth, Impacted studies →Universidad Complutense de Madrid is the lead sponsor of 206 studies on the registry; 64 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dexketoprofen pill at morning; Placebo at night
Drug: Dexketoprofen 25 MG
Placebo pill at morning; Dexketoprofen at night
Drug: Dexketoprofen 25 MG
Pill at morning
Also known as: Morning dosage
Pill at night
Also known as: Night dosage
Post operatory pain
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
Swelling
Distance from tragus to pogonion
Time frame: Baseline and post operatory (day 1, day 3, day 7)
Trismus
Open mouth limitation in milimiters, interincisal distance
Time frame: Baseline and post operatory (day 1, day 3 and day 7)
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)
Time frame: Baseline, day 3 and day 7
Plan to share: No
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This study is completed, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Dexketoprofen
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