Inflammatory Response, Pain, Tooth, Impacted, Trismus
Conditions
Keywords
Third, Dexketroprofen, Randomized
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.
Interventions
Pill at morning
Sponsors
McGill University
Universidad Complutense de Madrid
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* Bilateral impacted lower third molar
Exclusion criteria
* NSAID allergic * Contraindication of surgery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operatory pain | From the day of the surgical procedure to the seventh-day | Postoperatory pain with Visual Analogue Scale (VAS: 0 (no pain) to 10 (worst pain)) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Swelling | Baseline and post operatory (day 1, day 3, day 7) | Distance from tragus to pogonion |
Other
| Measure | Time frame | Description |
|---|---|---|
| Trismus | Baseline and post operatory (day 1, day 3 and day 7) | Open mouth limitation in milimiters, interincisal distance |
| Inflammatory profile for IL-1B, IL-6, IL-8, IL-10, TNF alpha | Baseline, day 3 and day 7 | Blood sample analysis for inflammatory cytokines in IU/ml by ELISA test (enzyme-linked immunoassay) |
Countries
Spain
Outcome results
None listed