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Dexamethasone in Lower Third Molar Surgery

Primary Purpose

Impacted Third Molar Tooth

Status
Completed
Phase
Phase 4
Locations
Serbia
Study Type
Interventional
Intervention
Intramuscular application
Submucosal application
4mg Dexamethasone submucosal
8mg Dexamethasone submucosal
4mg Dexamethasone preoperative
4mg Dexamethasone postoperative
Sponsored by
University of Belgrade
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Impacted Third Molar Tooth focused on measuring Dexamethasone, Lower third molar surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • School of Dental Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Experimental

Active Comparator

Experimental

Active Comparator

Experimental

Arm Label

Intramuscular application

Submucosal application

4mg Dexamethasone submucosal

8mg Dexamethasone submucosal

4mg Dexamethasone postoperative

4mg Dexamethasone preoperative

Arm Description

Intramuscular application of 4mg Dexamethasone

Submucosal application of 4mg Dexamethasone

4mg Dexamethasone submucosal application

8mg Dexamethasone submucosal application

4mg Dexamethasone postoperative application

4mg Dexamethasone postoperative application

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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".
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.
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.

Full Information

First Posted
April 2, 2015
Last Updated
April 19, 2019
Sponsor
University of Belgrade
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1. Study Identification

Unique Protocol Identification Number
NCT02416869
Brief Title
Dexamethasone in Lower Third Molar Surgery
Official Title
Effectiveness of Different Application Modalities of Dexamethasone on Clinical Parameters and Quality of Life After Lower Third Molar Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
April 2019 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Belgrade

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Impacted Third Molar Tooth
Keywords
Dexamethasone, Lower third molar surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intramuscular application
Arm Type
Active Comparator
Arm Description
Intramuscular application of 4mg Dexamethasone
Arm Title
Submucosal application
Arm Type
Experimental
Arm Description
Submucosal application of 4mg Dexamethasone
Arm Title
4mg Dexamethasone submucosal
Arm Type
Active Comparator
Arm Description
4mg Dexamethasone submucosal application
Arm Title
8mg Dexamethasone submucosal
Arm Type
Experimental
Arm Description
8mg Dexamethasone submucosal application
Arm Title
4mg Dexamethasone postoperative
Arm Type
Active Comparator
Arm Description
4mg Dexamethasone postoperative application
Arm Title
4mg Dexamethasone preoperative
Arm Type
Experimental
Arm Description
4mg Dexamethasone postoperative application
Intervention Type
Procedure
Intervention Name(s)
Intramuscular application
Intervention Description
Patient receive 4mg of Dexamethasone by intramuscular application
Intervention Type
Procedure
Intervention Name(s)
Submucosal application
Intervention Description
Patients receive 4mg of Dexamethasone by submucosal application
Intervention Type
Drug
Intervention Name(s)
4mg Dexamethasone submucosal
Other Intervention Name(s)
Dexasone
Intervention Description
Patients receive 4mg of submucosal Dexamethasone
Intervention Type
Drug
Intervention Name(s)
8mg Dexamethasone submucosal
Other Intervention Name(s)
Dexasone
Intervention Description
Patients receive 8mg of submucosal Dexamethasone
Intervention Type
Procedure
Intervention Name(s)
4mg Dexamethasone preoperative
Intervention Description
Patients receive 4mg of Dexamethasone preoperatively
Intervention Type
Procedure
Intervention Name(s)
4mg Dexamethasone postoperative
Intervention Description
Patients receive 4mg of Dexamethasone postoperatively
Primary Outcome Measure Information:
Title
Facial swelling (using 3 facial measurements (in millimeters)
Description
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.
Time Frame
1 day, 3 day, 7 day
Secondary Outcome Measure Information:
Title
Postoperative pain (visual analog scale)
Description
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".
Time Frame
1 day, 3 day, 7 day
Title
Postoperative trismus (difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery)
Description
Postoperative trismus will be measured as the difference in interincisal distance at the maximal mouth opening (in millimeters) before and after surgery.
Time Frame
1 day, 3 day, 7 day
Title
Postoperative discomfort (25-items custom made questionnaire)
Description
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.
Time Frame
4 day, 7 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Miroslav M Andric, DDS, PhD
Organizational Affiliation
School of Dental Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Dental Medicine
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia

12. IPD Sharing Statement

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Dexamethasone in Lower Third Molar Surgery

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