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IRCT20181205041860N1 IRCT 2019-09-26 Shahid Beheshti University of Medical Sciences Providing a therapeutic method for regeneration of damaged bone tissue in the oral and maxillofacial region by mononuclear cells isolated from the patient's own fat tissue Evaluation of the effect of adipose tissue - mononuclear cells (AT-NMCs) on maxillofacial bone regeneration: a randomized, controlled clinical trial and phase 1 2019-08-27 anticipated 20 Complete https://irct.ir/trial/41675 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, randomization is performed using the block method using SAS software. twenty patient will be involved in the study, which will be classified into two groups. to avoid identifying the last patient by medical staff, 5 blocks with 6 wells will be designed that only 4 wells per each block will be considered. To conceal randomization, each block will be placed in an envelope and all researchers will unaware of the contents of the envelopes. Therefore, a non-study individual was selected to perform all these steps to inform the physician of the result. N/A Patients with maxillofacial bone defects. Intervention 1: Intervention group: Patients with oral maxillofacial bone defect who receive autologous mononuclear cells isolated from adipose tissue with bone scaffolds (routine treatment) through oral maxillofacial surgery. Intervention 2: Control group: Patients with oral maxillofacial bone defect who receive bone scaffolds (or routine treatment) through oral maxilofacial surgery. 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 there are no more information
public Mahboubeh Bohlouli
arabi
tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9847 bohlouli98@gmail.com Shahid Beheshti University of Medical Sciences scientific Dr. Arash Khojasteh
arabi
tehran Iran (Islamic Republic of) 1985717443 +98 21 2243 9847 arashkhojasteh@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) The patient has a bone defect in the maxillofacial region no limit no limit Both The defect should not be socket, dehiscence, fenestration, and also sinus not involved. systemic and metabolic diseases active infection compromised immune system pregnant and or lactating women osteoporosis and osteopetrosis previous alveolar surgery smoking M89.3 Hypertrophy of bone Treatment - Surgery Treatment - Surgery Intervention group: Patients with oral maxillofacial bone defect who receive autologous mononuclear cells isolated from adipose tissue with bone scaffolds (routine treatment) through oral maxillofacial surgery Control group: Patients with oral maxillofacial bone defect who receive bone scaffolds (or routine treatment) through oral maxilofacial surgery In this study, safety is the main primary outcome. Timepoint: The patient will be visited one and six days as well as 1 and 6 months after surgery. But during this time, if patients have any abnormal clinical symptoms, you will be counseled or visited by telephone or in person. Method of measurement: To evaluate the safety, different parameters such as infection, inflammation, fibrosis tissue formation, local edema, local erythema, pain, dental implant rejection, dental sensitivity, and mortality will be evaluated through clinical evaluations, blood tests, CT scans Conical scans and scatological analyzes. New bone formation. Timepoint: after 6 months from surgery. Method of measurement: analysis of Cone Beam-CT data and histology images. Shahid Beheshti University of Medical Sciences Approved 2019-08-26 ethics committee of shahid beheshti university of medical science arabi tehran Tehran Iran (Islamic Republic of)