Efficacy of Chronoterapy in Oral Surgery

NCT ID: NCT05126264

Last Updated: 2022-02-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-10

Study Completion Date

2022-02-02

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Tooth, Impacted Trismus Pain Inflammatory Response

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Split-mouth design
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Modified dosage

Ibuprofen pill at morning and afternoon; Placebo at night

Group Type EXPERIMENTAL

Ibuprofen 400 mg

Intervention Type DRUG

morning and afternoon

Normal dosage

Ibuprofen three times a day: morning, afternoon and night

Group Type ACTIVE_COMPARATOR

Ibuprofen 400 mg

Intervention Type DRUG

morning, afternoon and night

Interventions

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Ibuprofen 400 mg

morning and afternoon

Intervention Type DRUG

Ibuprofen 400 mg

morning, afternoon and night

Intervention Type DRUG

Other Intervention Names

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Modified dosage Conventional dosage

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McGill University

OTHER

Sponsor Role collaborator

Universidad Complutense de Madrid

OTHER

Sponsor Role lead

Responsible Party

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Jesús Torres García Denche

Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fabian Perez Gonzalez

Madrid, , Spain

Site Status

Countries

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Spain

References

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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.

Reference Type BACKGROUND
PMID: 27816275 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28610818 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19955445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25995365 (View on PubMed)

Other Identifiers

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2019-000736-25

Identifier Type: -

Identifier Source: org_study_id

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