Efficacy of Chronoterapy in Oral Surgery

Pain Clinical Trial

— ECOS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05126264
• Other study ID #: 2019-000736-25
• Status: Completed
• Phase: N/A
• Start date: December 10, 2021
• Est. completion date: February 2, 2022

Study information

• Verified date: February 2022
• Source: Universidad Complutense de Madrid
• Contact: n/a
• Is FDA regulated: No
• 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 (ibuprofen) affects on postoperative pain, swelling and open mouth limitation comparing to the normal dosage.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: February 2, 2022
• Est. primary completion date: December 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Response
• Pain
• Tooth, Impacted
• Trismus

Intervention

Drug:
• Ibuprofen 400 mg
morning and afternoon
• Ibuprofen 400 mg
morning, afternoon and night

Locations

Country	Name	City	State
Spain	Fabian Perez Gonzalez	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Universidad Complutense de Madrid	McGill University

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Albuquerque AFM, Fonteles CSR, do Val DR, Chaves HV, Bezerra MM, Pereira KMA, de Barros Silva PG, de Lima BB, Soares ECS, Ribeiro TR, Costa FWG. Effect of pre-emptive analgesia on clinical parameters and tissue levels of TNF-a and IL-1ß in third molar surgery: a triple-blind, randomized, placebo-controlled study. Int J Oral Maxillofac Surg. 2017 Dec;46(12):1615-1625. doi: 10.1016/j.ijom.2017.05.007. Epub 2017 Jun 10. — View Citation

Curtis AM, Fagundes CT, Yang G, Palsson-McDermott EM, Wochal P, McGettrick AF, Foley NH, Early JO, Chen L, Zhang H, Xue C, Geiger SS, Hokamp K, Reilly MP, Coogan AN, Vigorito E, FitzGerald GA, O'Neill LA. Circadian control of innate immunity in macrophages by miR-155 targeting Bmal1. Proc Natl Acad Sci U S A. 2015 Jun 9;112(23):7231-6. doi: 10.1073/pnas.1501327112. Epub 2015 May 20. — View Citation

Gutiérrez-Corrales A, Campano-Cuevas E, Castillo-Dalí G, Serrera-Figallo MÁ, Torres-Lagares D, Gutiérrez-Pérez JL. Relationship between salivary biomarkers and postoperative swelling after the extraction of impacted lower third molars. Int J Oral Maxillofac Surg. 2017 Feb;46(2):243-249. doi: 10.1016/j.ijom.2016.10.005. Epub 2016 Nov 3. — View Citation

Keller M, Mazuch J, Abraham U, Eom GD, Herzog ED, Volk HD, Kramer A, Maier B. A circadian clock in macrophages controls inflammatory immune responses. Proc Natl Acad Sci U S A. 2009 Dec 15;106(50):21407-12. doi: 10.1073/pnas.0906361106. Epub 2009 Dec 1. — View Citation

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)
Primary	Post operative Pain	Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)	From the day of the surgical procedure to the seventh-day
Secondary	Swelling	Distance from tragus to pogonion in milimiters	Baseline and post operatory (day 1, day 3, day 7)