Dexamethasone in Lower Third Molar Surgery

NCT ID: NCT02416869

Last Updated: 2019-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2019-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Impacted Third Molar Tooth

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Intramuscular application

Intramuscular application of 4mg Dexamethasone

Group Type ACTIVE_COMPARATOR

Intramuscular application

Intervention Type PROCEDURE

Patient receive 4mg of Dexamethasone by intramuscular application

Submucosal application

Submucosal application of 4mg Dexamethasone

Group Type EXPERIMENTAL

Submucosal application

Intervention Type PROCEDURE

Patients receive 4mg of Dexamethasone by submucosal application

4mg Dexamethasone submucosal

4mg Dexamethasone submucosal application

Group Type ACTIVE_COMPARATOR

4mg Dexamethasone submucosal

Intervention Type DRUG

Patients receive 4mg of submucosal Dexamethasone

8mg Dexamethasone submucosal

8mg Dexamethasone submucosal application

Group Type EXPERIMENTAL

8mg Dexamethasone submucosal

Intervention Type DRUG

Patients receive 8mg of submucosal Dexamethasone

4mg Dexamethasone postoperative

4mg Dexamethasone postoperative application

Group Type ACTIVE_COMPARATOR

4mg Dexamethasone preoperative

Intervention Type PROCEDURE

Patients receive 4mg of Dexamethasone preoperatively

4mg Dexamethasone preoperative

4mg Dexamethasone postoperative application

Group Type EXPERIMENTAL

4mg Dexamethasone postoperative

Intervention Type PROCEDURE

Patients receive 4mg of Dexamethasone postoperatively

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Intramuscular application

Patient receive 4mg of Dexamethasone by intramuscular application

Intervention Type PROCEDURE

Submucosal application

Patients receive 4mg of Dexamethasone by submucosal application

Intervention Type PROCEDURE

4mg Dexamethasone submucosal

Patients receive 4mg of submucosal Dexamethasone

Intervention Type DRUG

8mg Dexamethasone submucosal

Patients receive 8mg of submucosal Dexamethasone

Intervention Type DRUG

4mg Dexamethasone preoperative

Patients receive 4mg of Dexamethasone preoperatively

Intervention Type PROCEDURE

4mg Dexamethasone postoperative

Patients receive 4mg of Dexamethasone postoperatively

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Dexasone Dexasone

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Belgrade

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Miroslav Andric

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Miroslav M Andric, DDS, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Zagreb

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

School of Dental Medicine

Belgrade, , Serbia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Serbia

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

36/11-2013

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Use of Corticosteroids in Third Molar Surgery
NCT05752305 COMPLETED PHASE2/PHASE3