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CompletedNCT02665533Updated Aug 19, 2016

Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery

An interventional study of Dexamethasone and Diclofenac Sodium associated with Codeine in Pain, Edema and Trismus, sponsored by Federal University of the Valleys of Jequitinhonha and Mucuri. Completed at 1 site in Brazil. Open to participants aged 18 Years to 35 Years. Per ClinicalTrials.gov, last updated 2016-08-19.

Sponsored by Federal University of the Valleys of Jequitinhonha and Mucuri · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
18
Allocation
Randomized
Ages
18 Years to 35 Years
Sex
All
01

Study 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.

Read the detailed description

The surgery of third molar is usually associated with important post-surgical sequelae. The damage caused to tissue and bone may result in considerable pain, edema and trismus. The symptoms start gradually, peaking in 2 days after the extraction. The use of medications such as dexamethasone and diclofenac associated to codeine may support the prevention of post-surgical pain. This clinical trial aim compare the 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.

02

Conditions studied

  • Pain
  • Edema
  • Trismus

Keywords

  • pain measurement
  • edema
  • trismus
03

In context

Pain

2,450 studies on the registry are indexed under Pain; 945 are open to participants now.

This study's enrollment of 18 is below the median of 70 across 2,101 interventional studies indexed under Pain.

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Lead sponsor

Federal University of the Valleys of Jequitinhonha and Mucuri is the lead sponsor of 21 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
18 participants (actual)

Study arms

  • Active comparator
    Dexamethasone

    Dexamethasone 8 mg, one capsule single preoperative dose.

    Drug: Dexamethasone

  • Experimental
    Diclofenac Sodium associated with Codeine

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

    Drug: Diclofenac Sodium associated with Codeine

Interventions

  • Dexamethasone 8 mg

    Also known as: Dexamethasone Acetate

  • DrugDiclofenac Sodium associated with Codeine

    Diclofenac Sodium 50 mg associated with Codeine 50 mg

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to seven days post-surgical

  2. 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.

    Time frame: Up to seven days post-surgical

  3. 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.

    Time frame: Up to seven days post-surgical

Secondary outcomes

  1. Analgesic consumption

    Time frame: Up to seven days post-surgical

  2. Duration of surgery

    Time frame: Up to seven days post-surgical

07

Study locations

1 site
  • Universidade Federal dos Vales do Jequitinhonha e Mucuri
    Diamantina, Minas Gerais 39100000, Brazil
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2016, a primary completion of Jan 2016 and a completion of Jul 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jan 20, 2016
First posted
Jan 27, 2016
Start
Jan 2016
Primary completionActual
Jan 2016
CompletionActual
Jul 2016
Last update
Aug 19, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 19, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02665533
Lead sponsor
Federal University of the Valleys of Jequitinhonha and Mucuri
Responsible party
Sponsor
First posted
Jan 27, 2016
Start date
Jan 2016
Primary completion
Jan 2016
Completion
Jul 2016
Last update
Aug 19, 2016

Study contacts

Thiago Lima
principal investigator · Federal University of the Valleys of Jequitinhonha and Mucuri

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.

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