Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus

Evaluation of the Effects of Pre-operative Deflazacort on Post-operative Pain, Edema and Trismus in Impacted Lower Third Molar Surgery

Removal of impacted lower third molar teeth is one of the most common oral surgical procedures, and these operations often lead to various complications in patients. Antibiotics, analgesics and/or anti-inflammatory drugs are prescribed for the treatment of complications encountered. Anti-inflammatory is the property of a substance or treatment that reduces inflammation or swelling. Anti-inflammatory drugs make up about half of analgesics, remedying pain by reducing inflammation as opposed to opioids, which affect the central nervous system to block pain signaling to the brain. Based on this information, in this study, it is aimed to evaluate the effects of deflazacort preoperatively on the postoperative pain, swelling and trismus.

Study Overview

• Status: Active, not recruiting
• Conditions: Impacted Third Molar Tooth
• Intervention / Treatment: Drug: Deflazacort 30 MG Oral Tablet; Drug: Sugar pill

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 4

Contacts and Locations

Study Locations

• Turkey
  • Tuşba
    • Van, Tuşba, Turkey, 65080
      • Van Yuzuncu Yil University, Faculty of Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 36 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• absence of any systemic disease,
• having bilateral impacted mandibular third molar teeth in a similar position
• absence of allergy to any of the drugs used in the study,
• absence of pregnancy/lactating state,
• no history of any medication use during at least 2 week before the operation.

Exclusion Criteria:

• not regularly coming to the controls,
• not using their medicines regularly,
• using any additional medication that may affect the outcome of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deflazacort; Deflazacort is a glucocorticoid used as an anti-inflammatory drug. We used deflazacort 30 mg tablet. Patient took a pill once preoperatively (1 hour ago) in third molar surgery.	Drug: Deflazacort 30 MG Oral Tablet; After the taken a deflazacort pill once preoperatively (one hour ago), local anesthesia was obtained using 2 ml articaine hydrochloride 40 mg/ml with epinephrine 0.01 mg/ml . The horizontal incision was made with no. 15 scalpel blade and a full thickness mucoperiosteal flap was raised. In all surgical procedures, bone removal and/or tooth sectioning were performed under sterile saline irrigation. Following the extraction, granulation tissues were removed, and bleeding was controlled. Finally, the mucoperiosteal flap was repositioned by 3.0 silk sutures.; Other Names: FLANTADIN 30 MG 10 TABLET
Placebo Comparator: Sugar pill; Placebo is an inert substance or treatment which is designed to have no therapeutic value. Patients took sugar pill for plasebo once one hour before operation.	Drug: Sugar pill; Sugar pill

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Trismus	Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 2nd day
Postoperative Trismus	Postoperative trismus was evaluated by the maximum distance between the incisive borders of the upper and lower right incisive teeth which was measured with a caliper.	Postoperative 7th day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 1st day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 2nd day
Postoperative Edema	Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.	Postoperative 2nd day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 3d day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 4th day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 5th day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 6th day
Postoperative Pain	Patients were requested to mark their pain intensity on a pain assessment form using a visual analoge scale (VAS) ranging between 0 (no pain) to 10 (most severe pain).	Postoperative 7th day
Postoperative Edema	Postoperative edema was evaluated by the distance between predetermined facial anatomic landmarks (from the mandibular angle to lateral corner of the eye, base of the nose, labial commissura, and soft tissue pogonion) which was measured with using thread and millimeter ruler.	Postoperative 7th day

Collaborators and Investigators

• Sponsor: Yuzuncu Yıl University

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2018
• Primary Completion (Estimated): November 15, 2023
• Study Completion (Estimated): December 15, 2023

Study Registration Dates

• First Submitted: April 24, 2020
• First Submitted That Met QC Criteria: April 27, 2020
• First Posted (Actual): April 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 22, 2023
• Last Update Submitted That Met QC Criteria: August 20, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: pain; edema; trismus; deflazacort
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Stomatognathic Diseases; Neuromuscular Manifestations; Tooth Diseases; Spasm; Pain, Postoperative; Tooth, Impacted; Trismus; Physiological Effects of Drugs; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Deflazacort
• Other Study ID Numbers: 19.07.2017/06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No