A Phase 4 interventional study of Deflazacort 30 MG Oral Tablet and Sugar pill in Impacted Third Molar Tooth, sponsored by Yuzuncu Yıl University. Active, not recruiting at 1 site in Turkey. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2023-08-22.
Sponsored by Yuzuncu Yıl University · Phase 4, Interventional, and Prevention
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.
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This study's enrollment of 35 is below the median of 66 across 8,493 interventional studies indexed under Pain.
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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
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
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.
Also known as: FLANTADIN 30 MG 10 TABLET
Sugar pill
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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: Postoperative 7th 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.
Time frame: Postoperative 7th day
Plan to share: No
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Started Dec 2018 (actual). Primary completion is estimated for Nov 2023, 59 months after the start.
Of 280 non-industry phase 4 interventional studies under Pain, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 35. This study's planned 59 months is above that.
Counting every sponsor, half of 295 studies reached it within 18 months; a quarter within 8 and three quarters within 33.
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This study is active, not recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Deflazacort