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IRCT20150114020663N7 IRCT 2021-10-31 Tabriz University of Medical Sciences Evaluation and comparision of surgical outcomes and complications of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital فرنولوم زبان Evaluation and comparision of surgical outcomes of frenectomy in infants with ankyloglossia using electrocoutery or surgical in Tabriz pedriatric hospital 2021-11-11 anticipated 40 Complete https://irct.ir/trial/58651 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients will be randomly assigned to intervention and control groups. Patients are distributed in two groups (random sequence) using a table of random numbers. Patients are divided between the two groups by announcing the number of patients in the clinic. Odd numbers in one group and even numbers in the second group. Patients are selected in the clinic of Tabriz Children's Hospital. N/A Ankyloglossia. Intervention 1: Intervention group: Electrocautery. In this group of patients, the patient's tongue follicle is removed using the cauterization device in the operating room of Tabriz Children's Hospital. The cutter degree is set to cut 8. The incision is performed by the surgeon in one session and after the end of the work, the patient is monitored for recovery from bleeding under the tongue and edema. Intervention 2: Control group: surgery. In this group, patients undergo tongue follicle resection by traditional surgical method after general anesthesia using anesthesia and restoration with 0.4 vicryl suture. It is controlled for bleeding under the tongue and edema. No - There is not a plan to make this available Justification or reason for not sharing IPD is "No more information"
public Davoud Badebarin
Medical Faculty, Adjacent to the Emam Reza hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5165678691 +98 41 3526 2257 badebarind@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Davoud Badebarin
Medical Faculty, Adjacent to the Emam Reza hospital, Golgasht Street
Tabriz Iran (Islamic Republic of) 5165678691 +98 41 3526 2257 badebarind@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) age6 months to 2 years No previous procedure for ankyloglossia Acceptance of research terms and procedures by parents Lack of effective oral and tongue disease in the study results Diagnosis of Ankyloglossia 6 months 2 years Both Age above 2 years Previous surgery on the tongue Severe adhesion of the tongue to the floor of the mouth Another severe underlying disease Q38.1 Ankyloglossia Treatment - Surgery Treatment - Other Intervention group: Electrocautery. In this group of patients, the patient's tongue follicle is removed using the cauterization device in the operating room of Tabriz Children's Hospital. The cutter degree is set to cut 8. The incision is performed by the surgeon in one session and after the end of the work, the patient is monitored for recovery from bleeding under the tongue and edema. Control group: surgery. In this group, patients undergo tongue follicle resection by traditional surgical method after general anesthesia using anesthesia and restoration with 0.4 vicryl suture. It is controlled for bleeding under the tongue and edema. Answer to surgical or electrocautery treatment of the tongue ferronolum. Timepoint: 6 months. Method of measurement: Physical examination. Good baby nutrition. Timepoint: 6month and 1 year. Method of measurement: Weighing. Tabriz University of Medical Sciences Approved 2021-10-04 Ethics Committee of Tabriz University of Medical Sciences Tabriz University of Medical Sciences., Golgasht St., Azadi St Tabriz East Azarbaijan Iran (Islamic Republic of)