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IRCT20221220056881N1 IRCT 2022-12-30 ChitoTech Effect of Bonehem in Hemostasis Comparison of Gelfoam and Bonehem in dental socket bleeding control in patients on low-dose Aspirin 2022-12-22 anticipated 30 Complete https://irct.ir/trial/67535 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: People are randomly allocated to one of the three study groups using a random number and receive the intervention based on the group. First, a random number is allocated to each group; Coefficients of the number 3 are allocated to the first group, coefficients of 3 plus 1 are allocated to the second group, and coefficients of 3 plus 2 are allocated to the third group. For the distribution of the patients to each group, first, the direction of reading the numbers from the table is determined and then the researcher touches one of the numbers randomly and moves in one of the predetermined directions and records the numbers, and assigns the patient to the specified group, Blinding description: The study will be double-blinded. Patients are blinded to the type of intervention, and the researcher who has to enter the data into the checklist will be blinded to the type of intervention. 3 Bleeding after extraction of mandibular first and second molar teeth. Intervention 1: Intervention group: a single Gelfoam (Surgifoam, Ethicon) is used on the dental socket after extraction without suturing the socket. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze. Intervention 2: Intervention group: a single Bonhem (from Chitotech company, based on hydroxyapatite and bioglass) is used on the dental socket after extraction without suturing the socket. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze. Intervention 3: Control group: A 3-0 silk (Supasil) figure-of-eight suture is used to suture the dental socket after extraction. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze. Yes - There is a plan to make this available What will be shared: Related medical information, clinical information, results of the study When: Approximately 6 months after publishment To whom: Researchers working in academic and scientific institutions Conditions: More detailed information about the study can be provided to competent researchers interested in the subject of the study Where to obtain: Author (Mohammad Hassan Mirtaleb) via email: mirtalebmohamad@gmail.com How to obtain: Competent and enthusiastic researchers can receive data documentation after the publication of the work from the corresponding author by providing their academic information and identification. Comments:
public Mohammad Hassan Mirtaleb
Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2217 5350 mirtalebmohamad@gmail.com Shahid Beheshti University of Medical Sciences scientific Doctor Fateme Latifi
Shahid Beheshti Dental School, Daneshjoo Blvd., Evin, Chamran Highway, Tehran
Tehran Iran (Islamic Republic of) 1983963113 +98 21 2990 2307 dr.f.latifi@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Healthy patients (ASA I/II) Under treatment with a single 80mg dose of Aspirin tablet daily Candidate for non-surgical removal of mandibular first and second molar teeth 30 years 75 years Both T81.0 Haemorrhage and haematoma complicating a procedure, not elsewhere classified Treatment - Drugs Treatment - Drugs Treatment - Surgery Intervention group: a single Gelfoam (Surgifoam, Ethicon) is used on the dental socket after extraction without suturing the socket. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze. Intervention group: a single Bonhem (from Chitotech company, based on hydroxyapatite and bioglass) is used on the dental socket after extraction without suturing the socket. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze. Control group: A 3-0 silk (Supasil) figure-of-eight suture is used to suture the dental socket after extraction. A 10x10 sterile gauze is then placed on the socket and the patient is guided to slowly bite on the gauze. Socket haemorrhage. Timepoint: 24 hours after tooth extraction. Method of measurement: number of sterile gauze required to stop bleeding after tooth extraction. ChitoTech Approved 2022-11-14 Shahid Beheshti University of Medical Sciences Ethics Committee Shahid Beheshti University of Medical Sciences, Daneshjoo Blvd., Evin, Chamran Highway, Tehran Tehran Tehran Iran (Islamic Republic of)