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

Phase 4

Active, not recruiting

• Conditions: Impacted Third Molar Tooth
• Interventions: Drug: Deflazacort 30 MG Oral Tablet; Drug: Sugar pill

• Registration Number: NCT04365088
• Lead Sponsor: Yuzuncu Yıl University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-15
• Study First Submitted: 2020-04-24
• Study First Submitted QC: 2020-04-27
• Study First Posted: 2020-04-28
• Status Verified: 2023-08
• Last Update Submitted: 2023-08-20
• Last Update Posted: 2023-08-22
• Primary Completion: 2023-11-15
• Study Completion: 2023-12-15

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 35

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Deflazacort	Deflazacort 30 MG Oral Tablet	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.
Sugar pill	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	Postoperative 7th day	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 Edema	Postoperative 7th day	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 Trismus	Postoperative 7th day	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.

Trial Locations

Locations (1)

Van Yuzuncu Yil University, Faculty of Dentistry; 🇹🇷 Van, Tuşba, Turkey