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IRCT20210515051308N1 IRCT 2021-06-25 Esfahan University of Medical Sciences Evaluation of Alveolar Cleft Repair With Two Bone Grafting Methods The success evaluation of bone grafts treatment in patients with unilateral alveolar cleft using mixture of allograft and symphisis bone compared to iliac bone graft alone 2017-03-21 anticipated 22 Complete https://irct.ir/trial/56299 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients are selected by available sampling. Simple randomization based on a table of random numbers will be done . according to this participants will dividing into intervention and control groups, Blinding description: 1)The Advantages and Disadvantages of Both Treatments Were Explained to Patients Who Entered the Study. Patients Entered the Treatment Phase with Informed Consent but Were Not Alert Which Method Will be Used in the Operation Room. 2)The Radiologists, Who Examined the Dimensions of the Alveolar Cleft and Repair Using CBCT, Did Not Alert Which Surgical Procedure Would be Used for the Patient. N/A unilateral alveolar cleft. Intervention 1: Intervention group: Cortical bone fragments were extracted from the chin symphysis. For this purpose, sulcular incision of canine to canine was made in the mandible, 3 to 5 pieces of monocortical bone were extracted by a 6 mm trephine bur (Meisinger, Dusseldorf, Germany). The soft tissue incision was then sutured. A piece of the chin symphysis cortical bone was placed under the nasal mucosa. The other pieces were divided into smaller sizes and mixed with 2 to 5 mm allografts (Cenobone, Kish, Iran, two thirds autograft, one third allograft). The mixture filled the entire cleft area. Intervention 2: Control group: In these patients, a standard incision was used to access the anterior iliac crest. Based on the approximate size of the alveolar defect, a corticocancellous bone fragment was removed from the medial cortex of the anterior iliac crest by osteotome and mallet. The donor area (iliac) was sutured in three layers after washing. The extracted bone fragment was divided into smaller pieces and packed inside the alveolar defect so that a cortical wall was placed under the nasal mucosa. Yes - There is a plan to make this available What will be shared: personal data of participants and results of the study except patients name and family can be shared When: Access will start after the article is published To whom: Researchers working in academic and scientific institutions Conditions: in order to perform similar research, various analyzes can be done Where to obtain: Dr. Davood Davari davooddavari2011@yahoo.com. How to obtain: After sending the email, the documents will be sent within a week. Comments:
public Davood Davari
Koorosh Bilding., Sajad Ave., Atash(Meghdad) St., Khayam Highway
Esfahan Iran (Islamic Republic of) 8184973641 +98 31 3234 9543 davooddavari2011@yahoo.com Esfahan University of Medical Sciences scientific Davood Davari
Koorosh Bilding., Sajad Ave., Atash(Meghdad) St., Khayam Highway
Esfahan Iran (Islamic Republic of) 8184973641 +98 31 3234 9543 davooddavari2011@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) Patients with Unilateral Alveolar Cleft Patients with Mixed Dentition Informed Consent for Studing Treatment Methods 8 years 14 years Both Bilateral alveolar cleft History of previous surgery in the area History of radiotherapy in the area Existence of systemic disease Q37.1 Cleft hard palate with unilateral cleft lip Treatment - Surgery Treatment - Surgery Intervention group: Cortical bone fragments were extracted from the chin symphysis. For this purpose, sulcular incision of canine to canine was made in the mandible, 3 to 5 pieces of monocortical bone were extracted by a 6 mm trephine bur (Meisinger, Dusseldorf, Germany). The soft tissue incision was then sutured. A piece of the chin symphysis cortical bone was placed under the nasal mucosa. The other pieces were divided into smaller sizes and mixed with 2 to 5 mm allografts (Cenobone, Kish, Iran, two thirds autograft, one third allograft). The mixture filled the entire cleft area. Control group: In these patients, a standard incision was used to access the anterior iliac crest. Based on the approximate size of the alveolar defect, a corticocancellous bone fragment was removed from the medial cortex of the anterior iliac crest by osteotome and mallet. The donor area (iliac) was sutured in three layers after washing. The extracted bone fragment was divided into smaller pieces and packed inside the alveolar defect so that a cortical wall was placed under the nasal mucosa. Percentage of Bone Formed in the Alveolar Cleft. Timepoint: Cleft Volume Measurement before Intervention and One Year after Surgery. Method of measurement: Cone-Beam Computed Tomography. Determining of Treatment Complications. Timepoint: 1 Week, 1 Month, 3 Month, 6 Month, 1 Year after Intervention. Method of measurement: Clinical Inspection. Esfahan University of Medical Sciences Approved 2021-05-20 Ethics committee of Isfahan University of Medical Sciences Koorosh Bilding., Sajad Ave., Atash(Meghdad) St., Khayam Highway esfahan Isfehan Iran (Islamic Republic of)