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IRCT20180905040955N2 IRCT 2022-01-09 Tabriz University of Medical Sciences Evaluation of the effect of orthokine on histological and radiographic characteristics of hard tissue after Horizontal Bone Augmentation and Socket Preservation surgery The effect of Aoutologus Conditioned Serum on histological and radiographic characteristics of hard tissue after Horizontal Bone Augmentation and Socket Preservation surgery 2021-08-23 anticipated 21 Complete https://irct.ir/trial/52521 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Other, Purpose: Supportive, Randomization description: A random sampling method is available among people referring to the periodontics department of Tabriz Dental School. The method of randomization is simple and its unit is individual. Our tool is to randomize the table of random numbers. Also, treatment was assigned to patients randomly. The type of treatment was identified by code A (intervention) and B (control) and placed inside sealed envelopes; The envelopes were then placed in a bag and shaken. Then, it was accidentally taken out of the bag, and after observing the code, the treatment was given to the patient. None of the patients were informed about the treatment of another patient. The evaluator was not aware of the type of treatment, Blinding description: Only the facilitator (supervisor) who is not involved in the collection and analysis of study data and the researcher who will place the material in two areas of the oral hard tissue will be aware of the study groupings and the researcher, the data analyzer And the test subject will be blinded. The study will be performed single blinded. In fact, the test subject will not be aware of the use of ACS in the surgical area. 3 Condition 1: Horizontal Bone Augmentation. Condition 2: Socket preservation. Intervention 1: Intervention group: According to the goal, 21 people will be studied to prove the hypothesis and achieve the desired goal. After preparing the volunteer patient psychologically and explaining the goals of the project and the cases of cooperation, written consent, CBCT radiographic image of the patient will be obtained and preoperative radiographic evaluations will be performed. One day before surgery 10 cc Blood will be prepared from the patients vein and immediately inject into a special orthokine syringe. The syringe will be then placed in an incubator at 37 ° C for 8 hours and then enters the centrifuge (3000 rpm for 10 minutes). After the centrifuge, the syringe will be removed from the machine and enters the 0.2 filter, then the syringe has two parts, The upper part will be carefully removed by syringe and will be stored as ACS in the refrigerator and will be used in site on the day of surgery. After local anesthesia injection and ensuring anesthesia, the patient will undergo horizontal bone augmentation surgery in the area. The incision will be done done using a blade No. 15 and crestal incision in the area will be created .Soft tissue will be elevated using periost elevators and site will be prepared to the placement of the ACS impregnated membrane . The collagen membrane with a thickness of 1.1 to 1.4 (Hamanand saz baft kish inc) will be impregnated with 1 ml ACS and 1 cc allogeneic bone graft 500 to 100 microns will be placed in the site. Soft tissue will be returned and sutured using 3-0 silk thread. The patients medications include chlorhexidine mouthwash, acetaminophen, and the patient will be advised after surgery. 4 months after surgery, the area for implant placement is evaluated. To examine the histological changes, after flap elevation in the observed areas for implant placement by crestal incision using blade number 15, bone samples will be removed from the implant placement area with the help of Meisingers trephine bur with a diameter of 1.1 mm and immediately placed in formalin. The above samples will be transferred to the histological laboratory to evaluate: 1. Alkaline phosphatase activity, 2. Tissue mineralization, 3. Number of cells per unit area (osteoblasts, osteoclasts, fibroblasts and inflammatory cells) and 4. Collagen amount (hematoxylin and eosin and alizarin staining red) .Also the samples will be sent to the medical genetics laboratory to evaluate Gene expansion (Type I collagen alpha1, Alkaline phosphatase, Osteocalcin, Runx 2, RANKL, GAPDH, OPG) .The CBCT radiograph will be taken and the radiographic evaluation of the changes in the two areas will be calculated using the amount of bone formed in the horizontal dimension as well as the Hansfield number. Intervention 2: Control group: According to the goal, 21 people will be studied to prove the hypothesis and achieve the desired goal. After preparing the volunteer patient psychologically and explaining the goals of the project and the cases of cooperation, written consent, CBCT radiographic image of the patient will be obtained and preoperative radiographic evaluations will be performed. After local anesthesia injection and ensuring anesthesia, the patient will undergo horizontal bone augmentation surgery in the area. The incision will be done done using a blade No. 15 and crestal incision in the area will be created .Soft tissue will be elevated using periost elevators and site will be prepared to the placement of the membrane . The collagen membrane with a thickness of 1.1 to 1.4 (Hamanand saz baft kish inc) and 1 cc allogeneic bone graft 500 to 100 microns will be placed in the site. Soft tissue will be returned and sutured using 3-0 silk thread. The patients medications include chlorhexidine mouthwash, acetaminophen, and the patient will be advised after surgery. 4 months after surgery, the area for implant placement is evaluated. To examine the histological changes, after flap elevation in the observed areas for implant placement by crestal incision using blade number 15, bone samples will be removed from the implant placement area with the help of Meisingers trephine bur with a diameter of 1.1 mm and immediately placed in formalin. The above samples will be transferred to the histological laboratory to evaluate: 1. Alkaline phosphatase activity, 2. Tissue mineralization, 3. Number of cells per unit area (osteoblasts, osteoclasts, fibroblasts and inflammatory cells) and 4. Collagen amount (hematoxylin and eosin and alizarin staining red) .Also the samples will be sent to the medical genetics laboratory to evaluate Gene expansion (Type I collagen alpha1, Alkaline phosphatase, Osteocalcin, Runx 2, RANKL, GAPDH, OPG) .The CBCT radiograph will be taken and the radiographic evaluation of the changes in the two areas will be calculated using the amount of bone formed in the horizontal dimension as well as the Hansfield number. 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 No decision made yet.
public Adileh Shirmohammadi
Daneshgah street
Tabriz Iran (Islamic Republic of) 5715938861 +98 44 3344 4598 hamidreza.mohammadi.pajuhan@gmail.com Tabriz University of Medical Sciences scientific Adileh Shirmohammadi
Daneshgah street
Tabriz Iran (Islamic Republic of) 5715938861 +98 44 3344 4598 hamidreza.mohammadi.pajuhan@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) The difficulty of surgery is the same compared to the other side based on the dimensions required for augmentation as well as the condition of the existing tooth before extraction and the condition of the ridge. Patients should require implant placement in site patients should be satisfied for surgery. no limit no limit Both presence of systemic diseases presence of history of using disruptive drugs in healing processes The patient does not want to have surgery Presence of metabolic bone diseases Treatment - Drugs Treatment - Drugs Intervention group: According to the goal, 21 people will be studied to prove the hypothesis and achieve the desired goal. After preparing the volunteer patient psychologically and explaining the goals of the project and the cases of cooperation, written consent, CBCT radiographic image of the patient will be obtained and preoperative radiographic evaluations will be performed. One day before surgery 10 cc Blood will be prepared from the patients vein and immediately inject into a special orthokine syringe. The syringe will be then placed in an incubator at 37 ° C for 8 hours and then enters the centrifuge (3000 rpm for 10 minutes). After the centrifuge, the syringe will be removed from the machine and enters the 0.2 filter, then the syringe has two parts, The upper part will be carefully removed by syringe and will be stored as ACS in the refrigerator and will be used in site on the day of surgery. After local anesthesia injection and ensuring anesthesia, the patient will undergo horizontal bone augmentation surgery in the area. The incision will be done done using a blade No. 15 and crestal incision in the area will be created .Soft tissue will be elevated using periost elevators and site will be prepared to the placement of the ACS impregnated membrane . The collagen membrane with a thickness of 1.1 to 1.4 (Hamanand saz baft kish inc) will be impregnated with 1 ml ACS and 1 cc allogeneic bone graft 500 to 100 microns will be placed in the site. Soft tissue will be returned and sutured using 3-0 silk thread. The patients medications include chlorhexidine mouthwash, acetaminophen, and the patient will be advised after surgery. 4 months after surgery, the area for implant placement is evaluated. To examine the histological changes, after flap elevation in the observed areas for implant placement by crestal incision using blade number 15, bone samples will be removed from the implant placement area with the help of Meisingers trephine bur with a diameter of 1.1 mm and immediately placed in formalin. The above samples will be transferred to the histological laboratory to evaluate: 1. Alkaline phosphatase activity, 2. Tissue mineralization, 3. Number of cells per unit area (osteoblasts, osteoclasts, fibroblasts and inflammatory cells) and 4. Collagen amount (hematoxylin and eosin and alizarin staining red) .Also the samples will be sent to the medical genetics laboratory to evaluate Gene expansion (Type I collagen alpha1, Alkaline phosphatase, Osteocalcin, Runx 2, RANKL, GAPDH, OPG) .The CBCT radiograph will be taken and the radiographic evaluation of the changes in the two areas will be calculated using the amount of bone formed in the horizontal dimension as well as the Hansfield number. Control group: According to the goal, 21 people will be studied to prove the hypothesis and achieve the desired goal. After preparing the volunteer patient psychologically and explaining the goals of the project and the cases of cooperation, written consent, CBCT radiographic image of the patient will be obtained and preoperative radiographic evaluations will be performed. After local anesthesia injection and ensuring anesthesia, the patient will undergo horizontal bone augmentation surgery in the area. The incision will be done done using a blade No. 15 and crestal incision in the area will be created .Soft tissue will be elevated using periost elevators and site will be prepared to the placement of the membrane . The collagen membrane with a thickness of 1.1 to 1.4 (Hamanand saz baft kish inc) and 1 cc allogeneic bone graft 500 to 100 microns will be placed in the site. Soft tissue will be returned and sutured using 3-0 silk thread. The patients medications include chlorhexidine mouthwash, acetaminophen, and the patient will be advised after surgery. 4 months after surgery, the area for implant placement is evaluated. To examine the histological changes, after flap elevation in the observed areas for implant placement by crestal incision using blade number 15, bone samples will be removed from the implant placement area with the help of Meisingers trephine bur with a diameter of 1.1 mm and immediately placed in formalin. The above samples will be transferred to the histological laboratory to evaluate: 1. Alkaline phosphatase activity, 2. Tissue mineralization, 3. Number of cells per unit area (osteoblasts, osteoclasts, fibroblasts and inflammatory cells) and 4. Collagen amount (hematoxylin and eosin and alizarin staining red) .Also the samples will be sent to the medical genetics laboratory to evaluate Gene expansion (Type I collagen alpha1, Alkaline phosphatase, Osteocalcin, Runx 2, RANKL, GAPDH, OPG) .The CBCT radiograph will be taken and the radiographic evaluation of the changes in the two areas will be calculated using the amount of bone formed in the horizontal dimension as well as the Hansfield number. Alkaline phosphatase activity. Timepoint: 4 months after surgery. Method of measurement: MultiSkanGo plate reader software. Issue mineralization rate. Timepoint: 4 months after surgery. Method of measurement: Investigation of mineralized areas in histological slide examination. Number of cells per unit area. Timepoint: 4 months after surgery. Method of measurement: Histological slide examination and MutikImage 2 software. The amount of collagen. Timepoint: 4 months after surgery. Method of measurement: Hematoxylin and eosin staining and TRAP, histological slide examination. Gene expansion. Timepoint: 4 months after surgery. Method of measurement: Reverse transcription PCR. Horizontal dimension of bone. Timepoint: 4 months after surgery. Method of measurement: Calculation from CBCT radiography. Hansfield number. Timepoint: 4 months after surgery. Method of measurement: Calculation from CBCT radiography. Vice Chancellor of research of Tabriz university of medical sciences Approved 2021-06-21 Research Ethics Committees of Tabriz University of Medical Sciences Daneshgah st,Faculty of dentistry Tabriz East Azarbaijan Iran (Islamic Republic of)