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Intraosseous vs Submucosal Injection of Dexamethasone

Effectiveness of Intraosseous Injection of Dexamethasone Following Impacted Mandibular Third Molar Removal (Randomized Controlled Clinical Trial)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04718077
Enrollment
38
Registered
2021-01-22
Start date
2020-08-01
Completion date
2020-12-30
Last updated
2021-01-22

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

Conditions

Tooth, Impacted

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.

Interventions

OTHERIntraosseus

IO dexamethasone injection Dexamethasone 4 mg

OTHERSubmucoal

SM dexamethasone injection Dexamethasone 4 mg

Sponsors

Hams Hamed Abdelrahman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in mouth openingbaseline, 1st, 3rd, 7th daysdetermined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper
change in swelling1st, 3rd, 14th daysassessed 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.
change in pain scores1st, 3rd, 7th daysPain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.

Secondary

MeasureTime frameDescription
change in early healing of periodontal soft tissue wound1st, 7th, 14th daysThe EHS is composed of 3 parameters: 1. Clinical signs of re-epithelization (CSR). 2. Clinical signs of haemostasis (CSH). 3. Clinical signs of inflammation (CSI).

Countries

Egypt

Outcome results

None listed

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