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IRCT20221216056831N1 IRCT 2022-12-28 Tabriz University of Medical Sciences Using growth factor to prepare the implant area Clinical and histologicalevaluation of socket preservation using concentrated growth factor for implant site preparation 2022-12-18 anticipated 45 Complete https://irct.ir/trial/67482 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: Random sampling will be done among the patients referred to the Faculty of Dentistry in Tabriz who are eligible for the study. The randomization method is simple and its unit is individual. Our tool for randomizing a table of random numbers. Based on this, the type of treatment is marked with codes A (intervention) and B (control) and placed inside the sealed envelopes. The envelopes are placed in a bag and mixed. Then it is randomly selected from the bag and treatment is given to the patient by observing the code. Patients do not know the type of intervention on each jaw side, Blinding description: This study is double-blind so the patients do not know about the type of intervention on each side of the jaw. The evaluating researcher will not know about the type of intervention performed. Patients know the type of material but do not know which side of the jaw will be used. N/A Dental implant. Intervention 1: Intervention group: In order to obtain concentrated growth factor, on the day of surgery, a 9 cc venous blood sample was taken from the patients and this sample will be centrifuged (Medifuge MF200; Silfradent®Srl, S. Sofia (FC), Italy) at a speed of 2400 to 2700 rpm. After tooth extraction, using a probe, the maximum socket diameter will be measured in both mesiodistal and palatal/lingual vestibule dimensions at the crestal level. One of the sockets will be filled with CGF and to preserve the biomaterial, a membrane prepared from CGF and a horizontal figure of 8 suture will be used on the socket. The pain level of the patients up to 7 days after the operation by visual analogue scale and the quality of the soft tissue of the area. Surgery (tissue color and consistency, pus discharge, bleeding) will be evaluated 7 days after extraction, through a modified version of Landry, Turnbull and Howley's Healing Index (HI). Finally, after 2 months, the patients will return and mesiodistal dimensions and vestibule palatal/lingual socket measured again from the dental socket will be sampled for histological evaluation. After fixation and decalcification, the samples will be stained with hematoxylin and eosin (H&E) and histomorphological factors (percentage of remaining scaffold, bone and connective tissue) will be evaluated. At the same time, implants will be placed in place and Guided Bone Regeneration will be performed if needed. Intervention 2: Control group: After tooth extraction, maximum socket diameter will be measured using a probe in both mesiodistal and palatal/lingual vestibule dimensions at the crestal level. The control socket will be restored automatically without any intervention. The pain level of patients up to 7 days after the operation by visual analogue scale and the quality of the soft tissue of the surgical area (tissue color and consistency, pus secretion, bleeding) 7 days after the extraction, through a modified version of Landry, Turnbull and Howley's Healing Index (HI) will be evaluated. Finally, after 2 months, the patients will return and mesiodistal dimensions and vestibule palatal/lingual socket measured again from the dental socket will be sampled for histological evaluation. After fixation and decalcification, the samples will be stained with hematoxylin and eosin (H&E) and histomorphological factors (percentage of remaining scaffold, bone and connective tissue) will be evaluated. At the same time, implants will be placed in place and Guided Bone Regeneration will be performed if needed. 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 is no further information
public Masoumeh Faramarzi
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166614711+98 +98 44 3344 4598 m.faramarzi@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Masoumeh Faramarzi
Faculty of Dentistry, Tabriz University of Medical Sciences, Golgasht St., Tabriz
Tabriz Iran (Islamic Republic of) 5166614711 +98 44 3344 4598 m.faramarzi@tbzmed.ac.ir Tabriz University of Medical Sciences Iran (Islamic Republic of) Implant candidate patients in the area of extracted teeth At least 18 years old No systemic problems 18 years no limit Both Smokers with more than 10 cigarettes per day Patients with allergies to any of the substances used in this study Patients undergoing head or neck radiation therapy or chemotherapy in the 12 months prior to surgery Pregnant or lactating patients Z96.5 Presence of tooth-root and mandibular implants Treatment - Other Treatment - Other Intervention group: In order to obtain concentrated growth factor, on the day of surgery, a 9 cc venous blood sample was taken from the patients and this sample will be centrifuged (Medifuge MF200; Silfradent®Srl, S. Sofia (FC), Italy) at a speed of 2400 to 2700 rpm. After tooth extraction, using a probe, the maximum socket diameter will be measured in both mesiodistal and palatal/lingual vestibule dimensions at the crestal level. One of the sockets will be filled with CGF and to preserve the biomaterial, a membrane prepared from CGF and a horizontal figure of 8 suture will be used on the socket. The pain level of the patients up to 7 days after the operation by visual analogue scale and the quality of the soft tissue of the area. Surgery (tissue color and consistency, pus discharge, bleeding) will be evaluated 7 days after extraction, through a modified version of Landry, Turnbull and Howley's Healing Index (HI). Finally, after 2 months, the patients will return and mesiodistal dimensions and vestibule palatal/lingual socket measured again from the dental socket will be sampled for histological evaluation. After fixation and decalcification, the samples will be stained with hematoxylin and eosin (H&E) and histomorphological factors (percentage of remaining scaffold, bone and connective tissue) will be evaluated. At the same time, implants will be placed in place and Guided Bone Regeneration will be performed if needed. Control group: After tooth extraction, maximum socket diameter will be measured using a probe in both mesiodistal and palatal/lingual vestibule dimensions at the crestal level. The control socket will be restored automatically without any intervention. The pain level of patients up to 7 days after the operation by visual analogue scale and the quality of the soft tissue of the surgical area (tissue color and consistency, pus secretion, bleeding) 7 days after the extraction, through a modified version of Landry, Turnbull and Howley's Healing Index (HI) will be evaluated. Finally, after 2 months, the patients will return and mesiodistal dimensions and vestibule palatal/lingual socket measured again from the dental socket will be sampled for histological evaluation. After fixation and decalcification, the samples will be stained with hematoxylin and eosin (H&E) and histomorphological factors (percentage of remaining scaffold, bone and connective tissue) will be evaluated. At the same time, implants will be placed in place and Guided Bone Regeneration will be performed if needed. Changes in mesiodistal (MD) and vestibulo-palatal/lingual (VP/L) dimensions. Timepoint: 2 months after the operation. Method of measurement: The maximum diameter of the socket is measured using the William probe and recorded in both the mesiodistal and vestibulo-lingual/palatal dimensions at the crestal level. The amount of pain. Timepoint: During 7 days after the operation. Method of measurement: Visual Analogue Scale. Soft tissue quality. Timepoint: 7 days after extraction. Method of measurement: The quality of the soft tissue of the surgical area (tissue color, tissue consistency, pus secretion, bleeding) will be evaluated through a modified version of Landry, Turnbull and Howley's Healing Index (HI). Histomorphological factors. Timepoint: After 2 months. Method of measurement: A sample will be taken from Saket for histological evaluation. After fixation and decalcification, the samples will be stained with hematoxylin and eosin (H&E) and histomorphological factors (percentage of remaining scaffold, bone and connective tissue) will be evaluated. Tabriz University of Medical Sciences Approved 2022-11-14 Ethics committee of Tabriz University of Medical Sciences Deputy of research and technology, 3rd Floor, Central building No. 2, Tabriz University of Medical Sciences, Golgasht St., Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)