Dexamethasone in Lower Third Molar Surgery

University of Belgrade

Status and phase: Completed; Phase 4

Conditions: Impacted Third Molar Tooth

Treatments: Drug: 4mg Dexamethasone submucosal; Procedure: 4mg Dexamethasone preoperative; Procedure: Submucosal application; Drug: 8mg Dexamethasone submucosal; Procedure: Intramuscular application; Procedure: 4mg Dexamethasone postoperative

Study type: Interventional

Funder types: Other

Identifiers

NCT02416869

36/11-2013

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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60 participants in 6 patient groups

Intramuscular application

Active Comparator group

Description:

Intramuscular application of 4mg Dexamethasone

Treatment:

Procedure: Intramuscular application

Submucosal application

Experimental group

Description:

Submucosal application of 4mg Dexamethasone

Treatment:

Procedure: Submucosal application

4mg Dexamethasone submucosal

Active Comparator group

Description:

4mg Dexamethasone submucosal application

Treatment:

Drug: 4mg Dexamethasone submucosal

8mg Dexamethasone submucosal

Experimental group

Description:

8mg Dexamethasone submucosal application

Treatment:

Drug: 8mg Dexamethasone submucosal

4mg Dexamethasone postoperative

Active Comparator group

Description:

4mg Dexamethasone postoperative application

Treatment:

Procedure: 4mg Dexamethasone preoperative

4mg Dexamethasone preoperative

Experimental group

Description:

4mg Dexamethasone postoperative application

Treatment:

Procedure: 4mg Dexamethasone postoperative