Dexketoprofen Dosage According to Chronotherapy
Primary Purpose
Tooth, Impacted, Trismus, Pain
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexketoprofen 25 MG
Dexketoprofen 25 MG
Sponsored by
About this trial
This is an interventional treatment trial for Tooth, Impacted focused on measuring Third, Dexketroprofen, Randomized
Eligibility Criteria
Inclusion Criteria:
- Bilateral impacted lower third molar
Exclusion Criteria:
- NSAID allergic
- Contraindication of surgery
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Morning dosage
Night dosage
Arm Description
Dexketoprofen pill at morning; Placebo at night
Placebo pill at morning; Dexketoprofen at night
Outcomes
Primary Outcome Measures
Post operatory pain
Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain))
Secondary Outcome Measures
Swelling
Distance from tragus to pogonion
Full Information
NCT ID
NCT05176158
First Posted
December 14, 2021
Last Updated
October 10, 2022
Sponsor
Universidad Complutense de Madrid
Collaborators
McGill University
1. Study Identification
Unique Protocol Identification Number
NCT05176158
Brief Title
Dexketoprofen Dosage According to Chronotherapy
Official Title
Efficacy of Dexketoprofen Prescribed According to the Circadian Rhythms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 1, 2023 (Anticipated)
Primary Completion Date
July 1, 2023 (Anticipated)
Study Completion Date
November 1, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
McGill University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted, Trismus, Pain, Inflammatory Response
Keywords
Third, Dexketroprofen, Randomized
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Morning dosage
Arm Type
Experimental
Arm Description
Dexketoprofen pill at morning; Placebo at night
Arm Title
Night dosage
Arm Type
Experimental
Arm Description
Placebo pill at morning; Dexketoprofen at night
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen 25 MG
Other Intervention Name(s)
Morning dosage
Intervention Description
Pill at morning
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen 25 MG
Other Intervention Name(s)
Night dosage
Intervention Description
Pill at night
Primary Outcome Measure Information:
Title
Post operatory pain
Description
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
Secondary Outcome Measure Information:
Title
Swelling
Description
Distance from tragus to pogonion
Time Frame
Baseline and post operatory (day 1, day 3, day 7)
Other Pre-specified Outcome Measures:
Title
Trismus
Description
Open mouth limitation in milimiters, interincisal distance
Time Frame
Baseline and post operatory (day 1, day 3 and day 7)
Title
Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha
Description
Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay)
Time Frame
Baseline, day 3 and day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Bilateral impacted lower third molar
Exclusion Criteria:
NSAID allergic
Contraindication of surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabian Perez-Gonzalez, DDM, MS
Phone
670716375
Email
fabianpe@ucm.es
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Dexketoprofen Dosage According to Chronotherapy
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