Dexamethasone in Lower Third Molar Surgery

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416869
• Other study ID #: 36/11-2013
• Status: Completed
• Phase: Phase 4
• Start date: January 2014
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Tooth, Impacted

Intervention

Procedure:
• Intramuscular application
Patient receive 4mg of Dexamethasone by intramuscular application
• Submucosal application
Patients receive 4mg of Dexamethasone by submucosal application

Drug:
• 4mg Dexamethasone submucosal
Patients receive 4mg of submucosal Dexamethasone
• 8mg Dexamethasone submucosal
Patients receive 8mg of submucosal Dexamethasone

Procedure:
• 4mg Dexamethasone preoperative
Patients receive 4mg of Dexamethasone preoperatively
• 4mg Dexamethasone postoperative
Patients receive 4mg of Dexamethasone postoperatively

Locations

Country	Name	City	State
Serbia	School of Dental Medicine	Belgrade

Sponsors (1)

Lead Sponsor	Collaborator
University of Belgrade

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Facial swelling (using 3 facial measurements (in millimeters)	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.	1 day, 3 day, 7 day
Secondary	Postoperative pain (visual analog scale)	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".	1 day, 3 day, 7 day
Secondary	Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)	Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.	1 day, 3 day, 7 day
Secondary	Postoperative discomfort (25-items custom made questionnaire)	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.	4 day, 7 day