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IRCT20230708058713N1 IRCT 2023-09-05 Tehran University of Medical Sciences The effect of bone grafting method and the material on bone formation comparison of the amount of bone structure by the GBR double-layer technique at the same time as placing the implant in the cosmetic area using FDBA and DFDBA 2023-04-04 anticipated 80 Complete https://irct.ir/trial/72103 interventional Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment. 2 3 to 4 mm narrow ridge with a 4-wall defect in the buccal two-thirds of the cosmetic area. Intervention 1: This study has two intervention groups as follows: the samples will be randomly divided into two groups of 40. In the first group, the implant intervention is performed at the same time as the two-layer technique GBR; Antibiotic prophylaxis is given before the procedure; Lidocaine infiltration anesthesia is used and the full thickness mucoperiosteal flap is performed without damaging the periosteum. The incision is made at the apex of the ridge while maintaining a sufficient amount of gingival attachment. Next, in the first group for GBR, 0.3 cc allograft FDBA with 500-1000 nm particles of CenoBone brand is placed in the first layer on the implant, and in the second layer, Ceno Membrane absorbable collagen membrane with a thickness of 0.6 1 mm; In the third layer, 0.3 cc DFDBA allograft with 500-1000 nm particles from Ceno Bone brand is placed, and finally intact periosteum is placed as the fourth layer. Intervention 2: Intervention group:In the second group, all steps are the same as the first group, with the difference that in the first layer, Ceno Bone brand DFDBA with particle size of 500 to 1000 nm is placed in the amount of 0.3 cc, and in the third layer, Ceno Bone brand FDBA with The size of the particles of 500 to 1000 nm is placed in the amount of 0.3 cc. Immediately after the treatment, CBCT is taken, and then the patient is called to close the Helling abutment six months after the treatment, and the amount of bone formation is measured in two groups. Yes - There is a plan to make this available What will be shared: Only information about the main outcome When: The access period starts 6 months after the results are published To whom: Relevant academic and scientific institutions Conditions: It can be used to improve clinical skills and increase productivity of oral surgeries Where to obtain: Azad Islamic School of Dentistry, address: Pasdaran, 9th Nistan street, contact number: 22564571 and postal code: 19585.175 How to obtain: The request will be made to Azad Islamic Medical Sciences Faculty and reviewed by the Research Council as soon as possible. Comments:
public Raofe Asghari
Ajodanie Avu. , 14th Street
Tehran Iran (Islamic Republic of) 1956817451 +98 21 2280 2041 Asghari.raha@yahoo.com Tehran University of Medical Sciences scientific Dr. Ashagh Lasemi
Pasdaran avu. , 9th neyestan street
Tehran Iran (Islamic Republic of) ۱۹۵۸۵-۱۷۵ +98 21 2256 4571 asghari.raha@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) All patients have ASA = 1 They have extracted their teeth in front of the maxilla and referred after soft tissue healing. Patients have a narrow ridge of 3 to 4 mm in the aesthetic zone. The primary stability of used implants is above 35. The age of the patients is 30 to 60 years. 30 years 60 years Both The patient does not have ideal systemic conditions (ASA should not be 1) The patient is over 60 years old. Treatment - Surgery Treatment - Surgery This study has two intervention groups as follows: the samples will be randomly divided into two groups of 40. In the first group, the implant intervention is performed at the same time as the two-layer technique GBR; Antibiotic prophylaxis is given before the procedure; Lidocaine infiltration anesthesia is used and the full thickness mucoperiosteal flap is performed without damaging the periosteum. The incision is made at the apex of the ridge while maintaining a sufficient amount of gingival attachment. Next, in the first group for GBR, 0.3 cc allograft FDBA with 500-1000 nm particles of CenoBone brand is placed in the first layer on the implant, and in the second layer, Ceno Membrane absorbable collagen membrane with a thickness of 0.6 1 mm; In the third layer, 0.3 cc DFDBA allograft with 500-1000 nm particles from Ceno Bone brand is placed, and finally intact periosteum is placed as the fourth layer. Intervention group:In the second group, all steps are the same as the first group, with the difference that in the first layer, Ceno Bone brand DFDBA with particle size of 500 to 1000 nm is placed in the amount of 0.3 cc, and in the third layer, Ceno Bone brand FDBA with The size of the particles of 500 to 1000 nm is placed in the amount of 0.3 cc. Immediately after the treatment, CBCT is taken, and then the patient is called to close the Helling abutment six months after the treatment, and the amount of bone formation is measured in two groups. Percentage of bone formation; Consistency of results. Timepoint: 6 months follow up. Method of measurement: The area filled in the cavity created in the bone using the comparison of two CBCTs at the beginning of the operation and 6 months follow-up. Tehran University of Medical Sciences Approved 2023-06-12 Research Ethics Committees of Islamic Azad University- Dental Branch Tehran - Iran Ghods town, simaye iran street ,The central headquarters of the Ministry of Health and Medical Education Tehran Tehran Iran (Islamic Republic of)