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Efficacy of Chronoterapy in Oral Surgery (ECOS)

Primary Purpose

Tooth, Impacted, Trismus, Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Ibuprofen 400 mg
Ibuprofen 400 mg
Sponsored by
Universidad Complutense de Madrid
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tooth, Impacted focused on measuring Third molar, Chronotherapy, Ibuprofen, Randomized

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Fabian Perez Gonzalez

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Modified dosage

Normal dosage

Arm Description

Ibuprofen pill at morning and afternoon; Placebo at night

Ibuprofen three times a day: morning, afternoon and night

Outcomes

Primary Outcome Measures

Post operative Pain
Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)

Secondary Outcome Measures

Swelling
Distance from tragus to pogonion in milimiters

Full Information

First Posted
October 14, 2021
Last Updated
February 2, 2022
Sponsor
Universidad Complutense de Madrid
Collaborators
McGill University
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1. Study Identification

Unique Protocol Identification Number
NCT05126264
Brief Title
Efficacy of Chronoterapy in Oral Surgery
Acronym
ECOS
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
December 10, 2021 (Actual)
Primary Completion Date
December 10, 2021 (Actual)
Study Completion Date
February 2, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Complutense de Madrid
Collaborators
McGill University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted, Trismus, Pain, Inflammatory Response
Keywords
Third molar, Chronotherapy, Ibuprofen, Randomized

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Split-mouth design
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Modified dosage
Arm Type
Experimental
Arm Description
Ibuprofen pill at morning and afternoon; Placebo at night
Arm Title
Normal dosage
Arm Type
Active Comparator
Arm Description
Ibuprofen three times a day: morning, afternoon and night
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Other Intervention Name(s)
Modified dosage
Intervention Description
morning and afternoon
Intervention Type
Drug
Intervention Name(s)
Ibuprofen 400 mg
Other Intervention Name(s)
Conventional dosage
Intervention Description
morning, afternoon and night
Primary Outcome Measure Information:
Title
Post operative Pain
Description
Postoperative pain with visual analogue scale (VAS) from 0 (no pain) to 10 (maximum pain)
Time Frame
From the day of the surgical procedure to the seventh-day
Secondary Outcome Measure Information:
Title
Swelling
Description
Distance from tragus to pogonion in milimiters
Time Frame
Baseline and post operatory (day 1, day 3, day 7)
Other Pre-specified Outcome Measures:
Title
Trismus
Description
Open mouth limitation in milimiters. Interincisal distance
Time Frame
Baseline and post operatory (day 1, day 3 and day 7)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Fabian Perez Gonzalez
City
Madrid
ZIP/Postal Code
28040
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
27816275
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.
Results Reference
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PubMed Identifier
28610818
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.
Results Reference
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PubMed Identifier
19955445
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.
Results Reference
background
PubMed Identifier
25995365
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.
Results Reference
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Efficacy of Chronoterapy in Oral Surgery

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