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Intraosseous vs Submucosal Injection of Dexamethasone

Primary Purpose

Tooth, Impacted

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Intraosseus
Submucoal
Sponsored by
Hams Hamed Abdelrahman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Tooth, Impacted

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria

  • Patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the Pell and Gregory classification 1933)
  • Healthy patient (American society of anesthesiologists class I status)
  • Patient age range from 18 to 40 years old.
  • Patient without any local inflammation or pathology.
  • Patient who will able to understand verbal and written instructions.

Exclusion criteria

  • Pregnant or breast-feeding women.
  • Patient had anti-inflammatory drugs within 2 weeks before the procedure.
  • Patient under radiotherapy or chemotherapy.
  • Habits (heavy smoking and alcoholic).
  • Allergy to drugs used in this study.
  • Patient under anticoagulant or corticosteroid therapy.

Sites / Locations

  • Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IO dexamethasone injection

SM dexamethasone injection.

Arm Description

Outcomes

Primary Outcome Measures

Change in mouth opening
determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
change in swelling
assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper Horizontal reference between the corner of the mouth and the tragus of the ear. Vertical reference between the lateral canthus and the angle of the mandible.
change in pain scores
Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.

Secondary Outcome Measures

change in early healing of periodontal soft tissue wound
The EHS is composed of 3 parameters: Clinical signs of re-epithelization (CSR). Clinical signs of haemostasis (CSH). Clinical signs of inflammation (CSI).

Full Information

First Posted
January 17, 2021
Last Updated
January 17, 2021
Sponsor
Hams Hamed Abdelrahman
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1. Study Identification

Unique Protocol Identification Number
NCT04718077
Brief Title
Intraosseous vs Submucosal Injection of Dexamethasone
Official Title
Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
December 30, 2020 (Actual)
Study Completion Date
December 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hams Hamed Abdelrahman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Thirty-eight patients were randomly divided into 2 groups; the intraosseous injection group of dexamethasone (4 mg) and the submucosal injection group. All surgeries were performed by one surgeon. Postoperative pain was evaluated by visual analog scale score immediately after surgery and on postoperative days 1, 3, and 7. Swelling (determined using two linear measurements) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper. Early healing of periodontal soft tissue wound was assessed by using Early Wound Healing Score (EHS) which composed of 3 parameters: clinical signs of re-epithelization (CSR), clinical signs of hemostasis (CSH), and clinical signs of inflammation (CSI) and were assessed on postoperative days 1, 7, and 14. Mouth opening (determined by measurement of the maximum inter-incisal distance) were assessed just before the surgery and on postoperative days 1, 3, and 7 by using a digital vernier caliper.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth, Impacted

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
38 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IO dexamethasone injection
Arm Type
Experimental
Arm Title
SM dexamethasone injection.
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Intraosseus
Intervention Description
IO dexamethasone injection Dexamethasone 4 mg
Intervention Type
Other
Intervention Name(s)
Submucoal
Intervention Description
SM dexamethasone injection Dexamethasone 4 mg
Primary Outcome Measure Information:
Title
Change in mouth opening
Description
determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
Time Frame
baseline, 1st, 3rd, 7th days
Title
change in swelling
Description
assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper Horizontal reference between the corner of the mouth and the tragus of the ear. Vertical reference between the lateral canthus and the angle of the mandible.
Time Frame
1st, 3rd, 14th days
Title
change in pain scores
Description
Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.
Time Frame
1st, 3rd, 7th days
Secondary Outcome Measure Information:
Title
change in early healing of periodontal soft tissue wound
Description
The EHS is composed of 3 parameters: Clinical signs of re-epithelization (CSR). Clinical signs of haemostasis (CSH). Clinical signs of inflammation (CSI).
Time Frame
1st, 7th, 14th days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria Patient complaining of impacted mandibular third molar mesioangular or horizontal, according to the Pell and Gregory classification 1933) Healthy patient (American society of anesthesiologists class I status) Patient age range from 18 to 40 years old. Patient without any local inflammation or pathology. Patient who will able to understand verbal and written instructions. Exclusion criteria Pregnant or breast-feeding women. Patient had anti-inflammatory drugs within 2 weeks before the procedure. Patient under radiotherapy or chemotherapy. Habits (heavy smoking and alcoholic). Allergy to drugs used in this study. Patient under anticoagulant or corticosteroid therapy.
Facility Information:
Facility Name
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
City
Alexandria
State/Province
Azarita
ZIP/Postal Code
00203
Country
Egypt

12. IPD Sharing Statement

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Intraosseous vs Submucosal Injection of Dexamethasone

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