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IRCT20210419051016N3 IRCT 2023-06-17 Esfahan University of Medical Sciences Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding Comparative Evaluation of the effect of tranexamic acid impregnated gauze with gelatamp in controlling bleeding after the extraction of four maxillary primary incisors in children candidates for dental treatment under general anesthesia 2023-04-16 anticipated 30 Complete https://irct.ir/trial/69399 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Crossover, Purpose: Treatment, Randomization description: Children who are candidates for extraction of primary teeth who refer to the hospital dental department of Isfahan Faculty of Dentistry during the study, if they are eligible, will be included in the study and will be randomly assigned by simple randomization method and individually with the help of a table of random numbers; In this method, the 'AB' order is considered for each odd number, and the 'BA' order is considered for each even number. Then a column is randomly selected from the table and if the first selected number is odd, the 'AB' order is applied which means the first patient is allocated in the A group and receives GELATAMP treatment, and as a result, the next patient is allocated to the B group and receives TRANEXAMIC ACID IMPREGNATED GAUZE treatment. Similarly, If the selected number is even, the 'BA' order is applied and the first patient is allocated in the B group and receives TRANEXAMIC ACID IMPREGNATED GAUZE treatment, and as a result, the next patient is allocated to the A group and receives GELATAMP treatment. This is repeated 15 times until you get 15 samples in each group, Blinding description: Outcome assessor was not aware of the type of material used for each tooth while evaluating the treated teeth clinically and radiographically. This study will be conducted in a double-blind manner so that the examining clinician and data analyst will not know the type of intervention. 3 Tranexamic Acid, Controlling Bleeding, Gelatamp. Intervention 1: The first intervention group: Gelatamp, after extraction for two teeth, two pieces of Gelatamp (Spongostan, Ferrosan, Denmark) will be placed half inside the socket and after a period of 4 weeks in the second phase of the study, the groups will be changed. Intervention 2: The second intervention group: Tranexamic acid impregnated gauze, a gauze with dimensions of 2 x 2, impregnated with 4cc of ampoule of tranexamic acid (Tranexip, Caspian Tamin, Iran) with a dose of 500 mg/5 ml will be applied to two similar teeth and after a period of 4 weeks in the second phase of the study, the groups will be changed. 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 There is no further information
public Dr. Maryam Hajiahmadi
Pediatric Dentistry department, Faculty of Dentistry, Isfahan University of Medical Sciences, Hezar jerib St.
Isfahan Iran (Islamic Republic of) 81746-73461 +98 31 3792 5539 dr.maryamhajiahmadi@gmail.com Esfahan University of Medical Sciences scientific Dr. Maryam Hajiahmadi
School of Dentistry, Isfahan University of Medical Sciences, Hezar Jerib St., Isfahan
Isfahan Iran (Islamic Republic of) ۸۱۷۴۶-۷۳۴۶۱ +98 31 3792 5539 dr.maryamhajiahmadi@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) The need to Extract Primary incisors Age 2 to 4 years Children are not affected to Congenital Hemorrhagic Diseases Children should not receive Anticoagulants The Child does not have a Mental or Physical Disability The Studied Teeth should have less than One-third root Resorption and unmaintainable Crowns Do not take Ibuprofen and Aspirin Painkillers before and after work The Child does not have Contraindications for General Anesthesia The Studied Child only needs to have four Primary incisors Extracted and another Tooth Extracted from the Patient If the Tooth is not Infected and the root has not Decayed to a large extent, it is included in the Study If They do not have Complications during General Anesthesia. (Hypoxia, Blood Pressure drop, Larynx Spasm, etc.) 2 years 4 years Both History of any uncontrolled systemic disease Patients whose parents do not consent to participate in the study for any reason Treatment - Other Treatment - Other The first intervention group: Gelatamp, after extraction for two teeth, two pieces of Gelatamp (Spongostan, Ferrosan, Denmark) will be placed half inside the socket and after a period of 4 weeks in the second phase of the study, the groups will be changed. The second intervention group: Tranexamic acid impregnated gauze, a gauze with dimensions of 2 x 2, impregnated with 4cc of ampoule of tranexamic acid (Tranexip, Caspian Tamin, Iran) with a dose of 500 mg/5 ml will be applied to two similar teeth and after a period of 4 weeks in the second phase of the study, the groups will be changed. Intensity of Bleeding. Timepoint: The determined time intervals are 10, 5, and 15 minutes after starting to use Gelatamp and gauze impregnated with Tranexamic acid. Method of measurement: Fanning scale. Bleeding Time. Timepoint: The determined time intervals are 10, 5, and 15 minutes after starting to use Gelatamp and gauze impregnated with Tranexamic acid. Method of measurement: Fanning scale. Oral Health. Timepoint: At the beginning of the study (before the start of the intervention) and Two weeks after the end of the intervention. Method of measurement: Examination of the child's mouth. Esfahan University of Medical Sciences Approved 2023-03-18 Ethics committee of Isfahan University of Medical Sciences Ground Floor, Faculty of Medicine, Building No. 3, Isfahan University of Medical Sciences,Hezar Jerib St., Isfahan , Phone number: 03137923080 Isfahan Isfehan Iran (Islamic Republic of)