Dexketoprofen Dosage According to Chronotherapy

Not Applicable

Completed

• Conditions: Tooth, Impacted; Inflammatory Response; Trismus; Pain
• Interventions: Drug: Dexketoprofen 25 MG

• Registration Number: NCT05176158
• Lead Sponsor: Universidad Complutense de Madrid

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.

Study Timeline

• Study First Submitted: 2021-12-14
• Study First Submitted QC: 2022-01-03
• Study First Posted: 2022-01-04
• Status Verified: 2022-10
• Study Start: 2024-11-01
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Last Update Submitted: 2024-11-30
• Last Update Posted: 2024-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Bilateral impacted lower third molar

Exclusion Criteria

• NSAID allergic
• Contraindication of surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Night dosage	Dexketoprofen 25 MG	Placebo pill at morning; Dexketoprofen at night
Morning dosage	Dexketoprofen 25 MG	Dexketoprofen pill at morning; Placebo at night

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Swelling	Baseline and post operatory (day 1, day 3, day 7)	Distance from tragus to pogonion

Trial Locations

Locations (1)

UCM; 🇪🇸 Madrid, Spain