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

Impacted Third Molar Tooth Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04365088
• Other study ID #: 19.07.2017/06
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: December 15, 2018
• Est. completion date: December 15, 2023

Study information

• Verified date: August 2023
• Source: Yuzuncu Yil University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 35
• Est. completion date: December 15, 2023
• Est. primary completion date: November 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Impacted Third Molar Tooth
• Pain, Postoperative
• Tooth, Impacted
• Trismus

Intervention

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.
• Sugar pill
Sugar pill

Locations

Country	Name	City	State
Turkey	Van Yuzuncu Yil University, Faculty of Dentistry	Van	Tusba

Sponsors (1)

Lead Sponsor	Collaborator
Yuzuncu Yil University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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