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| Name | Class |
|---|---|
| McGill University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified dosage | Experimental | Ibuprofen pill at morning and afternoon; Placebo at night |
|
| Normal dosage | Active Comparator | Ibuprofen three times a day: morning, afternoon and night |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ibuprofen 400 mg | Drug | morning and afternoon |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Swelling | Distance from tragus to pogonion in milimiters | Baseline and post operatory (day 1, day 3, day 7) |
| Measure | Description | Time Frame |
|---|---|---|
| Trismus | Open mouth limitation in milimiters. Interincisal distance | Baseline and post operatory (day 1, day 3 and day 7) |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fabian Perez Gonzalez | Madrid | 28040 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27816275 | Background | 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. | |
| 28610818 |
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| ID | Term |
|---|---|
| D014095 | Tooth, Impacted |
| D014313 | Trismus |
| D010146 | Pain |
| ID | Term |
|---|---|
| D014076 | Tooth Diseases |
| D009057 | Stomatognathic Diseases |
| D013035 | Spasm |
| D020879 | Neuromuscular Manifestations |
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| ID | Term |
|---|---|
| D007052 | Ibuprofen |
| ID | Term |
|---|---|
| D010666 | Phenylpropionates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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Split-mouth design
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| Ibuprofen 400 mg | Drug | morning, afternoon and night |
|
|
| 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. |
| 19955445 | Background | 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. |
| 25995365 | Background | 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. |
| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |