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OpenTrials
Completed

NCT Number: NCT02416869

Dexamethasone in Lower Third Molar Surgery

The aim of this randomized double-blind cross over clinical trial is to investigate effectiveness of different routes of applications (intramuscular and submucous at the site of surgery) and doses (4 mg and 8 mg) of Dexamethasone on swelling, trismus, pain and quality of life after lower third molar surgery.

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Key information

Conditions

Impacted Third Molar Tooth

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

School of Dental Medicine

Belgrade, 11000, Serbia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy patients (ASA I)
  • Bilateral symmetrically impacted lower third molars according to Pel-Gregory's and Winter's classification

Exclusion criteria

  • Heavy tobacco smokers
  • Drug and / or alcohol abusers

Treatment and study plan

Intramuscular application

Procedure

Patient receive 4mg of Dexamethasone by intramuscular application

Submucosal application

Procedure

Patients receive 4mg of Dexamethasone by submucosal application

4mg Dexamethasone submucosal

Drug

Patients receive 4mg of submucosal Dexamethasone

Other names: Dexasone

8mg Dexamethasone submucosal

Drug

Patients receive 8mg of submucosal Dexamethasone

Other names: Dexasone

4mg Dexamethasone preoperative

Procedure

Patients receive 4mg of Dexamethasone preoperatively

4mg Dexamethasone postoperative

Procedure

Patients receive 4mg of Dexamethasone postoperatively

Primary outcomes

  1. Facial swelling (using 3 facial measurements (in millimeters)

    Time frame: 1 day, 3 day, 7 day

    We followed facial swelling 1, 3 and 7 days after intervention.

    Swelling in the operation site will be evaluated using 3 facial measurements (in millimeters):

    • Tragus - Midline.
    • Tragus - Corner of the mouth
    • Gonion - Lateral canthus.

Secondary outcomes

  1. Postoperative pain (visual analog scale)

    Time frame: 1 day, 3 day, 7 day

    Postoperative pain will be evaluated using a visual analog scale, 100 mm in length ranging from 0 for " no pain" to 100 for "the worse imaginable pain".

  2. Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)

    Time frame: 1 day, 3 day, 7 day

    Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.

  3. Postoperative discomfort (25-items custom made questionnaire)

    Time frame: 4 day, 7 day

    Postoperative discomfort will be evaluated by filling out the 25-items custom made questionnaire that was designed to asses the patient's perception of adverse effects.

Sponsors and collaborators

Lead sponsor

University of Belgrade

Other

Registry information

Official study title

Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery

Important dates

Study start
2014
Primary completion
2019
Study completion
2019
First posted
Apr 15, 2015
Registry last updated
Apr 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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