NCT02665533

Brief Summary

The main aim of the study is to investigate the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jan 2016

Shorter than P25 for not_applicable pain

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

Study Start

First participant enrolled

January 1, 2016

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 27, 2016

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

August 19, 2016

Status Verified

January 1, 2016

Enrollment Period

Same day

First QC Date

January 20, 2016

Last Update Submit

August 18, 2016

Conditions

PainEdemaTrismus

Keywords

pain measurementedematrismus

Outcome Measures

Primary Outcomes (3)

  • Post-surgical swelling of third molar extraction determined using linear measures in the face

    During the post-surgical intervals of 24, 48 and 72 hours and seven days, the swelling was determined using linear measures in the face.

    Up to seven days post-surgical

  • Post-surgical trismus of third molar extraction determined by maximum mouth opening

    During the post-surgical intervals of 24, 48 and 72 hours and seven days, the trismus was determined by maximum mouth opening.

    Up to seven days post-surgical

  • Post-surgical pain of third molar extraction using visual analogic scale

    The post-surgical pain was self-recorded by the patient using visual analogic scale in intervals of 24, 48 and 72 hours and seven days.

    Up to seven days post-surgical

Secondary Outcomes (2)

  • Analgesic consumption

    Up to seven days post-surgical

  • Duration of surgery

    Up to seven days post-surgical

Study Arms (2)

Dexamethasone

ACTIVE COMPARATOR

Dexamethasone 8 mg, one capsule single preoperative dose.

Drug: Dexamethasone

Diclofenac Sodium associated with Codeine

EXPERIMENTAL

Diclofenac Sodium 50 mg associated with Codeine 50 mg, one capsule single preoperative dose.

Drug: Diclofenac Sodium associated with Codeine

Interventions

DexamethasoneDRUG

Dexamethasone 8 mg

Also known as: Dexamethasone Acetate
Dexamethasone
Diclofenac Sodium associated with CodeineDRUG

Diclofenac Sodium 50 mg associated with Codeine 50 mg

Diclofenac Sodium associated with Codeine

Eligibility Criteria

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

You may qualify if:

  • Patients with indication of asymptomatic bilateral extractions of lower third molars;
  • Aged 18 years or older;
  • Have a good health and no disease;

You may not qualify if:

  • Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universidade Federal dos Vales do Jequitinhonha e Mucuri

Diamantina, Minas Gerais, 39100000, Brazil

Location

MeSH Terms

Conditions

PainEdemaTrismus

Interventions

Dexamethasonedexamethasone acetateCodeine

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpasmNeuromuscular ManifestationsNervous System Diseases

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic Hydrocarbons

Study Officials

  • Thiago Lima

    Federal University of the Valleys of Jequitinhonha and Mucuri

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

January 27, 2016

Study Start

January 1, 2016

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

August 19, 2016

Record last verified: 2016-01

Locations

BR(1)