Clinical Trials Logo

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)
See also
  Status Clinical Trial Phase
Active, not recruiting NCT05559255 - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI N/A
Terminated NCT04356352 - Lidocaine, Esmolol, or Placebo to Relieve IV Propofol Pain Phase 2/Phase 3
Completed NCT04748367 - Leveraging on Immersive Virtual Reality to Reduce Pain and Anxiety in Children During Immunization in Primary Care N/A
Completed NCT05057988 - Virtual Empowered Relief for Chronic Pain N/A
Completed NCT04466111 - Observational, Post Market Study in Treating Chronic Upper Extremity Limb Pain
Recruiting NCT06206252 - Can Medical Cannabis Affect Opioid Use?
Completed NCT05868122 - A Study to Evaluate a Fixed Combination of Acetaminophen/Naproxen Sodium in Acute Postoperative Pain Following Bunionectomy Phase 3
Active, not recruiting NCT05006976 - A Naturalistic Trial of Nudging Clinicians in the Norwegian Sickness Absence Clinic. The NSAC Nudge Study N/A
Completed NCT03273114 - Cognitive Functional Therapy (CFT) Compared With Core Training Exercise and Manual Therapy (CORE-MT) in Patients With Chronic Low Back Pain N/A
Enrolling by invitation NCT06087432 - Is PNF Application Effective on Temporomandibular Dysfunction N/A
Completed NCT05508594 - Efficacy and Pharmacokinetic-Pharmacodynamic Relationship of Intranasally Administered Sufentanil, Ketamine, and CT001 Phase 2/Phase 3
Recruiting NCT03646955 - Partial Breast Versus no Irradiation for Women With Early Breast Cancer N/A
Active, not recruiting NCT03472300 - Prevalence of Self-disclosed Knee Trouble and Use of Treatments Among Elderly Individuals
Completed NCT03678168 - A Comparison Between Conventional Throat Packs and Pharyngeal Placement of Tampons in Rhinology Surgeries N/A
Completed NCT03286543 - Electrical Stimulation for the Treatment of Pain Following Total Knee Arthroplasty Using the SPRINT Beta System N/A
Completed NCT03931772 - Online Automated Self-Hypnosis Program N/A
Completed NCT02913027 - Can We Improve the Comfort of Pelvic Exams? N/A
Terminated NCT02181387 - Acetaminophen Use in Labor - Does Use of Acetaminophen Reduce Neuraxial Analgesic Drug Requirement During Labor? Phase 4
Recruiting NCT06032559 - Implementation and Effectiveness of Mindfulness Oriented Recovery Enhancement as an Adjunct to Methadone Treatment Phase 3
Active, not recruiting NCT03613155 - Assessment of Anxiety in Patients Treated by SMUR Toulouse and Receiving MEOPA as Part of Their Care