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IRCT20181215041988N1 IRCT 2019-07-11 Ardabil University of Medical Sciences Gelofen in wisdom tooth surgery The effect of locally applied gelofen in postoperative complication after wisdom tooth surgery 2019-06-08 anticipated 34 Complete https://irct.ir/trial/39781 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: This study will be performed as a randomized double-blind trial in which the patient and the examiner will be absolutely unaware of the contents of the envelope provided to the surgeon. To this end, a total of 34 apparently similar envelopes will be selected and placed in a 17 surgical card packs together with gelofen, and the other 17 surgical envelopes contain no gelofen. The surgeon chooses randomly one of the envelopes before surgery, and will perform the operation according to the envelope type, Blinding description: In this double-blind study, only the researcher( surgeon) will be informed of the main drug or placebo assigned to each patient. The participants will not be informed of the sucket contents of the surgery .The patient does not see a dental sucket during surgery and the evaluator is also absent during surgery.Neither the participant nor evaluator not know who is in which group . 2-3 Wisdom surgery. Intervention 1: The intervention group is treated with gelofen-containing gelfoam in the socket of wisdom teeth. The contents of a 400 mg gelofen tablet (Jaber-ibne Hayan Co., Iran) is discharged by a syringe containing 1 cc of gelofen, then transferred to the gelfoam(Apadanatac Co.,Iran). Intervention 2: Control group: The control group is treated with gelofen-free gelfoam (Apadanatak Co.، Iran. placebo)in the socket of wisdom teeth. 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 Pouyan Sigari
Ardabil university of medical sciences,Daneshgah Ave,Janbazan square,Ardabil Town
Ardabil Iran (Islamic Republic of) 5618953141 +98 21 4454 1504 P.Sigari@arums.ac.ir Ardabil University of Medical Sciences scientific Pouyan Sigari
Ardabil university of medical sciences,Daneshgah Ave,Janbazan square,Ardabil Town
Ardabil Iran (Islamic Republic of) 5618953141 +98 21 4454 1504 P.Sigari@arums.ac.ir Ardabil University of Medical Sciences Iran (Islamic Republic of) Having an impacted mandibular wisdom tooth Age between 14 and 65 years Signature of consent 14 years 65 years Both Systemic disease Pregnancy Drug abuse Using anti_ analgesic grug Y56.7 Dental drugs, topically applied Treatment - Drugs Placebo The intervention group is treated with gelofen-containing gelfoam in the socket of wisdom teeth. The contents of a 400 mg gelofen tablet (Jaber-ibne Hayan Co., Iran) is discharged by a syringe containing 1 cc of gelofen, then transferred to the gelfoam(Apadanatac Co.,Iran). Control group: The control group is treated with gelofen-free gelfoam (Apadanatak Co.، Iran. placebo)in the socket of wisdom teeth. Pain. Timepoint: 2,4,6,12,24,48 hours after surgery. Method of measurement: visual analogue scale. Bleeding. Timepoint: 2 days after surgery. Method of measurement: questionnaire. Swelling. Timepoint: 2 days after surgery. Method of measurement: Measured by ruler from comissure of lip_ lop of ear and countus of eye _ Angle of mandible. Trismus. Timepoint: 2 days after surgery. Method of measurement: distance between the upper and lower incisal edges in millimeters. Dry sucket. Timepoint: 2 days after surgery. Method of measurement: Examination. Ardabil University of Medical Sciences Approved 2019-05-25 The Ethics Committee of Ardabil University of Medical Sciences Vice President of Research،northern side of Ardabil University of Medical Sciences،University Square،University Street Ardabil Ardabil Iran (Islamic Republic of)