Efficacy of Chronoterapy in Oral Surgery

Not Applicable

Completed

• Conditions: Tooth, Impacted; Trismus; Pain; Inflammatory Response
• Interventions: Drug: Ibuprofen 400 mg

• Registration Number: NCT05126264
• 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 (ibuprofen) affects on postoperative pain, swelling and open mouth limitation comparing to the normal dosage.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2021-10-14
• Study First Submitted QC: 2021-11-16
• Study First Posted: 2021-11-18
• Study Start: 2021-12-10
• Primary Completion: 2021-12-10
• Status Verified: 2022-02
• Study Completion: 2022-02-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Normal dosage	Ibuprofen 400 mg	Ibuprofen three times a day: morning, afternoon and night
Modified dosage	Ibuprofen 400 mg	Ibuprofen pill at morning and afternoon; Placebo at night

Primary Outcome Measures

Name	Time	Method
Post operative Pain	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 Outcome Measures

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

Trial Locations

Locations (1)

Fabian Perez Gonzalez; 🇪🇸 Madrid, Spain