Intraosseous vs Submucosal Injection of Dexamethasone

NCT ID: NCT04718077

Last Updated: 2021-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-08-01
• Study Completion Date: 2020-12-30

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.

Conditions

Tooth, Impacted

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

IO dexamethasone injection

Group Type: EXPERIMENTAL

Intraosseus

Intervention Type: OTHER

IO dexamethasone injection Dexamethasone 4 mg

SM dexamethasone injection.

Group Type: ACTIVE_COMPARATOR

Submucoal

Intervention Type: OTHER

SM dexamethasone injection Dexamethasone 4 mg

Interventions

Intraosseus

IO dexamethasone injection Dexamethasone 4 mg

Intervention Type: OTHER

Submucoal

SM dexamethasone injection Dexamethasone 4 mg

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hams Hamed Abdelrahman

OTHER

Sponsor Role: lead

Responsible Party

Hams Hamed Abdelrahman

Assistant lecturer of DPH and Clinical statistician

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

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

Alexandria, Azarita, Egypt

Countries

Egypt

Other Identifiers

Corticosteriod

Identifier Type: -

Identifier Source: org_study_id