Clinical trial

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

Name
19.07.2017/06
Description
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.
Trial arms
Trial start
2018-12-15
Estimated PCD
2023-11-15
Trial end
2023-12-15
Status
Active (not recruiting)
Phase
Early phase I
Treatment
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.
Arms:
Deflazacort
Other names:
FLANTADIN 30 MG 10 TABLET
Sugar pill
Sugar pill
Arms:
Sugar pill
Size
35
Primary endpoint
Postoperative Pain
Postoperative 1st day
Postoperative Pain
Postoperative 2nd day
Postoperative Edema
Postoperative 2nd day
Postoperative Trismus
Postoperative 2nd day
Postoperative Pain
Postoperative 3d day
Postoperative Pain
Postoperative 4th day
Postoperative Pain
Postoperative 5th day
Postoperative Pain
Postoperative 6th day
Postoperative Pain
Postoperative 7th day
Postoperative Edema
Postoperative 7th day
Postoperative Trismus
Postoperative 7th day
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'FACTORIAL', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 35, 'type': 'ACTUAL'}}
Updated at
2023-08-22

1 organization

1 product

1 drug

1 indication