NCT05126264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
22 days until next milestone

Study Start

First participant enrolled

December 10, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2022

Completed
Last Updated

February 3, 2022

Status Verified

February 1, 2022

Enrollment Period

Same day

First QC Date

October 14, 2021

Last Update Submit

February 2, 2022

Conditions

Tooth, ImpactedTrismusPainInflammatory Response

Keywords

Third molarChronotherapyIbuprofenRandomized

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Swelling

    Baseline and post operatory (day 1, day 3, day 7)

Other Outcomes (1)

  • Trismus

    Baseline and post operatory (day 1, day 3 and day 7)

Study Arms (2)

Modified dosage

EXPERIMENTAL

Ibuprofen pill at morning and afternoon; Placebo at night

Drug: Ibuprofen 400 mg

Normal dosage

ACTIVE COMPARATOR

Ibuprofen three times a day: morning, afternoon and night

Drug: Ibuprofen 400 mg

Interventions

Ibuprofen 400 mgDRUG

morning and afternoon

Also known as: Modified dosage
Modified dosage

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 and 35 years old
  • Bilateral retained lower third molar

You may not qualify if:

  • NSAID allergic
  • Contraindication for surgical removal of third molar

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fabian Perez Gonzalez

Madrid, 28040, Spain

Location

Related Publications (4)

  • 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.

    PMID: 27816275BACKGROUND

  • 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.

    PMID: 28610818BACKGROUND

  • 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.

    PMID: 19955445BACKGROUND

  • 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.

    PMID: 25995365BACKGROUND

MeSH Terms

Conditions

Tooth, ImpactedTrismusPain

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesSpasmNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PhenylpropionatesAcids, CarbocyclicCarboxylic AcidsOrganic Chemicals

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: Split-mouth design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

October 14, 2021

First Posted

November 18, 2021

Study Start

December 10, 2021

Primary Completion

December 10, 2021

Study Completion

February 2, 2022

Last Updated

February 3, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)