Dexamethasone in Lower Third Molar Surgery

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02416869

Enrollment

Registered

2015-04-15

Start date

2014-01-31

Completion date

2019-04-30

Last updated

2019-04-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Impacted Third Molar Tooth

Keywords

Dexamethasone, Lower third molar surgery

Brief 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.

Interventions

PROCEDUREIntramuscular application

Patient receive 4mg of Dexamethasone by intramuscular application

PROCEDURESubmucosal application

Patients receive 4mg of Dexamethasone by submucosal application

DRUG4mg Dexamethasone submucosal

Patients receive 4mg of submucosal Dexamethasone

DRUG8mg Dexamethasone submucosal

Patients receive 8mg of submucosal Dexamethasone

PROCEDURE4mg Dexamethasone preoperative

Patients receive 4mg of Dexamethasone preoperatively

PROCEDURE4mg Dexamethasone postoperative

Patients receive 4mg of Dexamethasone postoperatively

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Facial swelling (using 3 facial measurements (in millimeters)	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): 1. Tragus - Midline. 2. Tragus - Corner of the mouth 3. Gonion - Lateral canthus.

Secondary

Measure	Time frame	Description
Postoperative pain (visual analog scale)	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.
Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)	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.
Postoperative discomfort (25-items custom made questionnaire)	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.

Countries

Serbia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026