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OpenTrials
Completed

NCT Number: NCT05126264

Efficacy of Chronoterapy in Oral Surgery

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 (ibuprofen) affects on postoperative pain, swelling and open mouth limitation comparing to the normal dosage.

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Key information

Conditions

Tooth, Impacted Inflammatory Response Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spasm Stomatognathic Diseases Tooth Diseases Trismus

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fabian Perez Gonzalez

Madrid, 28040, Spain

About this study

A randomized crossover split-mouth clinical trial will be performed. After third molar extractions, patients will be prescribed ramdomly in one side wit the normal medication dosage while the contralateral side will be prescribed a modified dosage. Moreover, a blood sample will be obtained to analize the inflammatory profile.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 35 years old
  • Bilateral retained lower third molar

Exclusion criteria

  • NSAID allergic
  • Contraindication for surgical removal of third molar

Treatment and study plan

Ibuprofen 400 mg

Drug

morning and afternoon

Other names: Modified dosage

Primary outcomes

  1. Post operative Pain

    Time frame: From the day of the surgical procedure to the seventh-day

    Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)

Secondary outcomes

  1. Swelling

    Time frame: Baseline and post operatory (day 1, day 3, day 7)

    Distance from tragus to pogonion in milimiters

Other outcomes

  1. Trismus

    Time frame: Baseline and post operatory (day 1, day 3 and day 7)

    Open mouth limitation in milimiters. Interincisal distance

Sponsors and collaborators

Lead sponsor

Universidad Complutense de Madrid

Other

Collaborators

  • McGill University

Registry information

Official study title

Efficacy of the Dosage of a Non-steroidal Anti-inflammatory (Ibuprofen) on Inflammation and Postoperative Pain After Lower Third Molar Surgery.

Acronym: ECOS

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Nov 18, 2021
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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