Dexketoprofen Dosage According to Chronotherapy
Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
1 other identifier
interventional
10
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2024
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 14, 2021
CompletedFirst Posted
Study publicly available on registry
January 4, 2022
CompletedStudy Start
First participant enrolled
November 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2024
CompletedDecember 4, 2024
October 1, 2022
Same day
December 14, 2021
November 30, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Swelling
Baseline and post operatory (day 1, day 3, day 7)
Other Outcomes (2)
Trismus
Baseline and post operatory (day 1, day 3 and day 7)
Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha
Baseline, day 3 and day 7
Study Arms (2)
Morning dosage
EXPERIMENTALDexketoprofen pill at morning; Placebo at night
Night dosage
EXPERIMENTALPlacebo pill at morning; Dexketoprofen at night
Interventions
Eligibility Criteria
You may qualify if:
- Bilateral impacted lower third molar
You may not qualify if:
- NSAID allergic
- Contraindication of surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Complutense de Madridlead
- McGill Universitycollaborator
Study Sites (1)
UCM
Madrid, 28040, Spain
Related Publications (1)
Perez-Gonzalez F, Abusamak M, Ruiz LV, Saez-Alcaide LM, Al-Waeli H, Tamimi F, Garcia-Denche JT. Dexketoprofen Time-Dependent Administration After Third Molar Extraction: A Pilot Randomized Cross-Over Controlled Trial. Clin Exp Dent Res. 2026 Feb;12(1):e70163. doi: 10.1002/cre2.70163.
PMID: 41510697DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate professor
Study Record Dates
First Submitted
December 14, 2021
First Posted
January 4, 2022
Study Start
November 1, 2024
Primary Completion
November 1, 2024
Study Completion
November 1, 2024
Last Updated
December 4, 2024
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share