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IRCT20210501051143N1 IRCT 2021-05-20 Esfahan University of Medical Sciences Investigation the effect of fibrin glue on alveolar graft Evaluation of the success rate of alveolar bone grafts using fibrin glue 2021-06-22 anticipated 20 Complete https://irct.ir/trial/55959 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, patients were selected based on the inclusion and exclusion criteria of two-digit codes from 10 to 30, and randomization was performed based on the lottery method. Assignment codes were written on paper and placed inside an envelope. One of the researchers will pick up the written code without looking inside the envelope and will be assigned to the control group (A) or intervention group (B) alternatively. It should be noted that after removing each of the codes, in order to equalize the chances of all people, the read code will be placed again in the envelope, and in case of re-pick up an assigned code, it will be considered as an empty option, Blinding description: Patients were randomly selected in such a way that they will be fully informed about the type of received treatment. Finally, the intervention effectiveness will be evaluated by the CBCT method compared to the control group. A specialist who is blind to the treatment procedures will assess the results, regardless of the control and intervention group, and report the results to each participant based on the assigned codes. N/A Unilateral alveolar cleft. Intervention 1: Control group: Includes ten patients with unilateral alveolar cleft who will undergo iliac crest bone graft surgery in the alveolar cleft area. After bone graft surgery, the nasal mucosa and palatal mucosa will be sutured. Intervention 2: Intervention group: Includes ten patients with unilateral alveolar cleft who will undergo iliac crest bone graft surgery in the alveolar cleft area. All interventions performed in this group will be completely similar to the control group, except for fibrin glue, which will be the only difference between the control group and the intervention group. After suturing the nasal mucosa and palatal mucosa, fibrin glue will be placed on the sutured part to prevent leaking bacteria into the transplant space. Yes - There is a plan to make this available What will be shared: Information about participants, including sex, age, the volume of alveolar cleft, and the amount of bone formed after the intervention in both control and intervention groups, can be published after the individuals have not been identified. When: The access period is immediately after publication the results To whom: Only people working in health care institutions and medical researchers Conditions: Researchers involved in the field related to this study, including evaluating the CBCT method to investigate bone volume or the effectiveness of fibrin glue in bone grafting Where to obtain: Isfahan University of Medical Sciences, Department of Oral and Maxillofacial Surgery, School of Dentistry, Dr. Bijan Movahedian Attar, b_movahedian@dnt.mui.ac.ir How to obtain: The applicant must provide the required documentation from a valid institution to receive the files Comments:
public Bijan Movahedian Attar
Department of Oral and Maxillofacial Surgery, School of Dentistry, Hezar Jerib St., University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 b_movahedian@dnt.mui.ac.ir Esfahan University of Medical Sciences scientific Bijan Movahedian Attar
Department of Oral and Maxillofacial Surgery, School of Dentistry, Hezar Jerib St., University of Medical Sciences and Health Services
Isfahan Iran (Islamic Republic of) 8174673461 +98 31 3668 0048 b_movahedian@dnt.mui.ac.ir Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with unilateral alveolar cleft Ages 6 to 12 years referred to Al-Zahra Hospital in Isfahan Conscious consent to participate in the study 6 years 12 years Both Bilateral alveolar cleft Presence of systemic diseases or pathological disorders History of chemotherapy or radiotherapy Patients with a history of unsuccessful alveolar transplantation K08.8 Other specified disorders of teeth and supporting structures Treatment - Surgery Treatment - Surgery Control group: Includes ten patients with unilateral alveolar cleft who will undergo iliac crest bone graft surgery in the alveolar cleft area. After bone graft surgery, the nasal mucosa and palatal mucosa will be sutured. Intervention group: Includes ten patients with unilateral alveolar cleft who will undergo iliac crest bone graft surgery in the alveolar cleft area. All interventions performed in this group will be completely similar to the control group, except for fibrin glue, which will be the only difference between the control group and the intervention group. After suturing the nasal mucosa and palatal mucosa, fibrin glue will be placed on the sutured part to prevent leaking bacteria into the transplant space. The volume of bone formed after transplantation. Timepoint: Before surgery and 4 months after bone graft. Method of measurement: Cone beam computed tomography method. Isfahan University of Medical Sciences Approved 2021-03-17 Research Ethics Committee of Isfahan University of Medical Sciences Hezar Jerib St., Central Headquarters, Isfahan University of Medical Sciences and Health Services Isfahan Isfehan Iran (Islamic Republic of)