Clinical trial NCT05126264: Efficacy of Chronoterapy in Oral Surgery
Official title: Efficacy of the Dosage of a Non-steroidal Anti-inflammatory (Ibuprofen) on Inflammation and Postoperative Pain After Lower Third Molar Surgery.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth, Impacted
Trismus
Pain
Inflammatory Response
Keywords: Third molar
Chronotherapy
Ibuprofen
Randomized
Lead sponsor: Universidad Complutense de Madrid
Sponsor class: OTHER
Collaborators: name: McGill University
First posted: 2021-11-18
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Split-mouth design
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Post operative Pain
timeFrame: From the day of the surgical procedure to the seventh-day
Secondary outcomes:
measure: Swelling
timeFrame: Baseline and post operatory (day 1, day 3, day 7)
Other outcomes:
measure: Trismus
timeFrame: Baseline and post operatory (day 1, day 3 and day 7)
Locations:
city: Madrid
country: Spain
facility: Fabian Perez Gonzalez
Study officials:
References:
citation: Gutierrez-Corrales A, Campano-Cuevas E, Castillo-Dali G, Serrera-Figallo MA, Torres-Lagares D, Gutierrez-Perez 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.
citation: 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-alpha and IL-1beta 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.
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.
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.