Intraosseous vs Submucosal Injection of Dexamethasone
Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)
1 other identifier
interventional
38
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2020
CompletedFirst Submitted
Initial submission to the registry
January 17, 2021
CompletedFirst Posted
Study publicly available on registry
January 22, 2021
CompletedJanuary 22, 2021
January 1, 2021
5 months
January 17, 2021
January 17, 2021
Conditions
Outcome Measures
Primary Outcomes (3)
Change in mouth opening
determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
baseline, 1st, 3rd, 7th days
change in swelling
assessed by measuring two linear references (horizontal and vertical) with digital vernier caliper 1. Horizontal reference between the corner of the mouth and the tragus of the ear. 2. Vertical reference between the lateral canthus and the angle of the mandible.
1st, 3rd, 14th days
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.
1st, 3rd, 7th days
Secondary Outcomes (1)
change in early healing of periodontal soft tissue wound
1st, 7th, 14th days
Study Arms (2)
IO dexamethasone injection
EXPERIMENTALSM dexamethasone injection.
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Outpatient Clinic of Oral and Maxillofacial Surgery Department, Faculty of Dentistry, Alexandria University, Egypt
Alexandria, Azarita, 00203, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Assistant lecturer of DPH and Clinical statistician
Study Record Dates
First Submitted
January 17, 2021
First Posted
January 22, 2021
Study Start
August 1, 2020
Primary Completion
December 30, 2020
Study Completion
December 30, 2020
Last Updated
January 22, 2021
Record last verified: 2021-01