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Completed

NCT Number: NCT04718077

Intraosseous vs Submucosal Injection of Dexamethasone

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.

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Key information

Conditions

Tooth, Impacted Stomatognathic Diseases Tooth Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Alexandria, Azarita, 00203, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Intraosseus

Other

IO dexamethasone injection Dexamethasone 4 mg

Submucoal

Other

SM dexamethasone injection Dexamethasone 4 mg

Primary outcomes

  1. Change in mouth opening

    Time frame: baseline, 1st, 3rd, 7th days

    determined by measurement of the maximum inter-incisal distance assessed by using a digital vernier caliper

  2. change in swelling

    Time frame: 1st, 3rd, 14th days

    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.

  3. change in pain scores

    Time frame: 1st, 3rd, 7th days

    Pain will be assessed by using a visual analog scale (VAS) (13) immediately after surgery and on postoperative days 1, 3, and 7.

Secondary outcomes

  1. change in early healing of periodontal soft tissue wound

    Time frame: 1st, 7th, 14th days

    The EHS is composed of 3 parameters:

    • Clinical signs of re-epithelization (CSR).
    • Clinical signs of haemostasis (CSH).
    • Clinical signs of inflammation (CSI).

Sponsors and collaborators

Lead sponsor

Hams Hamed Abdelrahman

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jan 22, 2021
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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