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IRCT20201227049849N1 IRCT 2021-01-13 Kashan University of Medical Sciences Effects of Platelet-rich-fibrin on Post-surgical Complications of Impacted wisdom tooth surgery Effects of Platelet-rich fibrin (PRF) on Post-surgical Complications of Impacted wisdom tooth surgery in adults 2021-01-09 anticipated 30 Complete https://irct.ir/trial/53303 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: For randomizing each left or right side wisdom tooth of cases in intervention or control group, at first, a randomizing list would be gotten from this website www. sealedenvelope.com/simple with Balanced (permuted) block randomization technic and based on the entrance number of each case, left or right side wisdom tooth of patients would be allocate to group A (control group) or group B (intervention group), Blinding description: Patient's blood samples would be gotten before each operation( whether for intervention side or control side).Therefore, patients would not be aware of intervention or control side. Data analyzer would receive the data as left side and right side instead of intervention side and control side. 3 Platelet-rich fibrin. Intervention 1: Intervention group: Placement of Platelet-rich fibrin taken from patient's blood sample in empty extracted tooth socket and suturing the flap with 3/0 silk cord. Intervention 2: Control group: Not placing any material in extracted tooth socket. Suturing the flap with 3/0 silk cord. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public امیرسالار سیدیاحسین
Pezeshk Blvd, Ghotb ravandi Ave
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 kiani-p@kaums.ac.ir Kashan University of Medical Sciences scientific Amirsalar Sayedyahossein
Pezeshk Blvd.Ghotb ravandi Ave
Kashan Iran (Islamic Republic of) 8715981151 +98 31 5554 0021 kiani-p@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Adults Patients with bilateral inter-bone impacted wisdom tooth no limit no limit Both Pregnancy Lactation Having pre-operative sign or symptom Existence of pathology in impaction area Allergy to Penicillin, Paracetamol, chlorhexidine Prevention N/A Intervention group: Placement of Platelet-rich fibrin taken from patient's blood sample in empty extracted tooth socket and suturing the flap with 3/0 silk cord Control group: Not placing any material in extracted tooth socket. Suturing the flap with 3/0 silk cord. Post-operative pain degree. Timepoint: First 7 days after surgery. Method of measurement: 0-10 Numeric Pain Rating Scale. Post-operative edema amount. Timepoint: 1,3 and 7 days after surgery. Method of measurement: The distance between tragus and mouth commissure in horizontal plane and the distance between lateral cantus and gonion in vertical plane, would be measured by a flexible band. Post-operative bleeding amount. Timepoint: 3 and 7 days after surgery. Method of measurement: Massive, uncontrollable bleeding since 2nd day of surgery would be conformed by patient. Post-operative infection manifestation. Timepoint: 4- 7 days after surgery. Method of measurement: Assessment of pus discharge, redness and temperature increasing after the 3rd day after surgery. Post-operative dry socket manifestation. Timepoint: 4- 7 days after surgery. Method of measurement: Presence of extreme pain not being decreased by taking analgesics and empty socket without pus discharge or fever. Kashan University of Medical Science Approved 2020-12-09 Ethics committee of Kashan University of Medical Science Pezeshk Blvd, Ghotb ravandi Ave Kashan Isfehan Iran (Islamic Republic of)