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IRCT20181022041411N1 IRCT 2018-12-07 Mashhad University of Medical Sciences Evaluation of success of low intensity ultrasound application in the reconstruction of alveolar bone Evaluation of clinical success of low intensity ultrasound application in comparison with conventional autogenous bone graft in the reconstruction of alveolar cleft defects in patients with clefts of hard palate and unilateral cleft of lips 2018-09-23 anticipated 14 Complete https://irct.ir/trial/35439 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The analyst will be unaware of the intervention and control groups because the data will be presented as anonymous code to the statistician. 2-3 Cleft hard palate with unilateral cleft lip. Intervention 1: Intervention group: From the day after the transplantation, patients will be subjected to pulsed ultrasound at low intensity for 1 minute at a frequency of 1 MHz and an intensity of 500 mW for 6 weeks. Intervention 2: Control group: The normal procedure will be performed with the autologous bone graft of the illiac region of the patient. 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 After analysis of the data, if it was found that the application of low intensity ultrasound is effective in palatal and lip cleft, the results will be published.
public Amirreza Mashreghi
Mashhad dental school, Vakilabad boulvard
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 mashreghia891@mums.ac.ir Mashhad University of Medical Sciences scientific Arezoo Jahanbin
Mashhad dental school, Vakilabad Boulvard
Mashhad Iran (Islamic Republic of) 9177948959 +98 51 3882 9501 jahanbina@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with unilateral palate and lips cleft Patients who their palatal bone has been expanded Parental informed consent 9 years 13 years Both Patients with bilateral palate and lips clefts Patients with other syndromes Patients who can not be surgically treated because of medical problems Q37.1 Cleft hard palate with unilateral cleft lip Treatment - Other Treatment - Surgery Intervention group: From the day after the transplantation, patients will be subjected to pulsed ultrasound at low intensity for 1 minute at a frequency of 1 MHz and an intensity of 500 mW for 6 weeks. Control group: The normal procedure will be performed with the autologous bone graft of the illiac region of the patient The progression of the graft repair and the pattern of affected adjacent tooth. Timepoint: 1, 3 and 6 months after bone graft surgery. Method of measurement: Radiographic images of CBCT, occlusal and periapical. Deputy of Research of Mashhad University of Medical Sciences Mashhad University of Medical Sciences Deputy of Research of Mashhad University of Medical Sciences Approved 2018-05-16 Faculty of Dentistry-Mashhad University of Medical Sciences Mashhad dental school, Vakilabad Boulevard Mashhad Razavi Khorasan Iran (Islamic Republic of)