ECOS: Efficacy of Chronoterapy in Oral Surgery
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Modified dosage Ibuprofen pill at morning and afternoon; Placebo at night |
Drug: Ibuprofen 400 mg
morning and afternoon
Other Names:
|
| Active Comparator: Normal dosage Ibuprofen three times a day: morning, afternoon and night |
Drug: Ibuprofen 400 mg
morning, afternoon and night
Other Names:
|
Outcome Measures
Primary Outcome Measures
- 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
- Swelling [Baseline and post operatory (day 1, day 3, day 7)]
Distance from tragus to pogonion in milimiters
Other Outcome Measures
- Trismus [Baseline and post operatory (day 1, day 3 and day 7)]
Open mouth limitation in milimiters. Interincisal distance
Eligibility Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Fabian Perez Gonzalez | Madrid | Spain | 28040 |
Sponsors and Collaborators
- Universidad Complutense de Madrid
- McGill University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- 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-α and IL-1β 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.
- 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.
- 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.
- 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.
- 2019-000736-25