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IRCT20191002044949N1 IRCT 2022-01-11 Shahid Beheshti University of Medical Sciences Reconstruction of palatal cleft using 3D printer Investigation of the effect of a 3D printed biocompatible composite scaffold customized for the patient with the use of buccal fat pad micrograft on regeneration of bone defects in the patients with palatal and alveolar bone cleft 2021-04-20 anticipated 10 Complete https://irct.ir/trial/54180 interventional Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: The investigators has not been informed about the patients' code. Investigators include a radiologist for obtaining CBCT and a person who evaluate informations by Materialise Mimics (3D Medical Image Processing Software). 1 Maxillary alveolar cleft. Intervention 1: Intervention group: Gelatin (5-20 wt%)/ alginate (1-4 wt%)/ allograft (10-40 wt%) in combination with buccal fat pad micrograft. Gelatin with medical grade is purchased from Nitta Gelatin Co, China, Alginate with medical grade from KIMICA co, Japan, and allograft bone powder from Iranian Tissue Product company (RegenTM). Buccal fat pad micrograft is obtain by using a novel mechanical device, called Minceolip, was patented by our team in the Intellectual Property Office of Real Estate Registration Organization of Iran (Application Number 13985040003006638). Safety of Buccal fat pad micrograft was performed clinically according to a study approved by the Ethical Committee of the Shahid Beheshti University of Medical Sciences (Approval number IR.SBMU.REC.1398.061), and Iranian Registry of Clinical Trials (IRCT) with IRCT code 20181205041860N1 on September 26, 2019. Intervention 2: Control group: Autogenous bone graft harvested from anterior crest of iliac bone which is the gold standard treatment of alveolar bone defects reconstruction. Yes - There is a plan to make this available What will be shared: Only demographic factors information such as age and gender, and CBCT images and clinical views of surgery can be shared by a scientific article when the patient is unidentifiable. When: The data will become available 6 months after publication. To whom: All researchers can apply to receive the data. Conditions: It is possible for researchers to use our data or documentation to conduct research and clinical studies while maintaining ethical conditions. Where to obtain: Applicants can contact Dr. Farshid Bastami with the following information and express their application: Email: farshidbst@gmail.com Tel: 00989126704434 How to obtain: Applicants must submit a clear length of the email and submit their application. After evaluating the applicant and his/her request, he/she will be given an appropriate response at the earliest time (at least after a week). Comments:
public Farshid Bastami
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo st, Velenjak
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 farshidbst@gmail.com Shahid Beheshti University of Medical Sciences scientific Farshid Bastami
School of Dentistry, Shahid Beheshti University of Medical Sciences, Daneshjoo st, Velenjak
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2217 5350 farshidbst@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patient with alveolar or palatal cleft Defect size more than 2 cm3 soft tissue deficiency is not seen maxillary sinus is not involved Dental dehiscence or fenestration is not seen 10 years no limit Both autoimmune or metabolic or systemic diseases peripheral vascular diseases marble bone disease or osteoporosis smoking or alcohol consuption conditions which compromise wound healing process being in breastfeeding or pregnancy Rehabilitation Rehabilitation Intervention group: Gelatin (5-20 wt%)/ alginate (1-4 wt%)/ allograft (10-40 wt%) in combination with buccal fat pad micrograft. Gelatin with medical grade is purchased from Nitta Gelatin Co, China, Alginate with medical grade from KIMICA co, Japan, and allograft bone powder from Iranian Tissue Product company (RegenTM). Buccal fat pad micrograft is obtain by using a novel mechanical device, called Minceolip, was patented by our team in the Intellectual Property Office of Real Estate Registration Organization of Iran (Application Number 13985040003006638). Safety of Buccal fat pad micrograft was performed clinically according to a study approved by the Ethical Committee of the Shahid Beheshti University of Medical Sciences (Approval number IR.SBMU.REC.1398.061), and Iranian Registry of Clinical Trials (IRCT) with IRCT code 20181205041860N1 on September 26, 2019. Control group: Autogenous bone graft harvested from anterior crest of iliac bone which is the gold standard treatment of alveolar bone defects reconstruction. Height, width and length of the ridge at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: CBCT scan. New formed bone density at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Radio morphometry using CBCT scan. Native bone and scaffold contact at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: CBCT scan. The rate of new bone formation at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining. The rate of fibrosis or necrosis if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining. Foreign body reaction if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining. The rate of scaffold remnants if exists at the alveolar defect site in test group in comparison with the control group. Timepoint: 6 month after surgery. Method of measurement: Histologic assessment by H&E staining. Shahid Beheshti University of Medical Sciences Approved 2019-06-17 Ethics committee, School of Dentistry, Shahid Beheshti Univerisity of Medical Sciences Evin, Daneshju boulevard Tehran Tehran Iran (Islamic Republic of)