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IRCT20101204005305N22 IRCT 2024-11-10 Kerman University of Medical Sciences The comparison of platelet-rich-fibrin impregnated alloderm Vs free gingival grafts Vs Alloderm to increase keratinized gingival width around dental implants The comparison of Alloderm with platelet rich fibrin(PRF) Vs free gingival grafts Vs Alloderm to increase the width of keratinized tissue around dental implants : a randomised controlled trial 2024-12-30 anticipated 36 Complete https://irct.ir/trial/80007 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients is done by block randomized method, which is as follows: 3 sequences of 12 letters A’B’C are produced and people are entered into the study in groups of 12, then each sequence is removed from its envelope and people Based on it, they are assigned to study groups, Blinding description: The need to increase the width of the attached gingiva in these people was determined by a periodontist who does not know the type of treatment. A clinician that is blind to the study will perform all measurements. Patients in all groups receive surgery, but they are not informed about the surgical technique that is performed. However, care and complications after surgery are comprehensively explained. N/A width of keratinized tissue around dental implants. Intervention 1: Intervention group: 1- First, ten milliliters of whole venous blood will be collected in two sterile PRF preparation tubes of ten milliliters.2- The tubes will be inserted into the centrifuge at a speed of 700 rpm for 3 minutes.3- Blood is divided into three layers. A cell-free plasma, a middle section containing a fibrin clot, and a red section containing red blood cells at the bottom of the tube.4- PRF is drawn with a syringe.5- Then Eloderm is prepared in the same way as described in the previous group6- Now Alloderm with PRF will be mixed and fixed with periosteal sutures using 0-5 non-absorbable nylon suture material on the recipient site. Intervention 2: Intervention group:In the ADM group, the acellular dermal matrix (AlloDerm®) will be prepared and applied according to the manufacturer's instructions. In summary:1- The membrane will be hydrated with 50 ml of sterile saline solution for 5 minutes.2- When the protective backing paper is removed, the ADM substance will be transferred to another container containing 50 ml of sterile serum solution and will be left there for 5 minutes.3- Then, the allograft will be cut to a size of one by two centimeters4- It will be fixed on the recipient site with periosteal sutures using 0-5 non-absorbable nylon suture material. Intervention 3: Control group:For the control group:1. Taking a 1 to 2 mm thick FGG from the palate, depending on the amount of tissue in the palate of each patient and with dimensions of 1 x 1.5 cm2. Placement and fixation of FGG on the recipient surface with crossed sutures and non-absorbable sutures (Nylon 5.0, Ethilon®). 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 more information
public mohammad mohammadi
shafa street Dental School
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 mmohammadi28@yahoo.com Kerman University of Medical Sciences scientific Dr. Mohammad Mohammadi
Periodontics Department, Kerman Dental School, Shafa Street
Kerman Iran (Islamic Republic of) 7618759689 +98 34 3211 9021 mmohammadi28@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) less than 2mm keratinized gingiva healthy periimplant tissue plaque index and bleeding index less than 20% good overal health 18 years no limit Both smokers(more than 10 cigarettes per day) Patients with systemic diseases that can interfere with recovery. Patients treated with bisphosphonates and patients who have previously received jaw radiotherapy. Patients with moderate to severe periodontitis. Pregnant women and nursing mothers. Treatment - Surgery Treatment - Surgery Treatment - Surgery Intervention group: 1- First, ten milliliters of whole venous blood will be collected in two sterile PRF preparation tubes of ten milliliters.2- The tubes will be inserted into the centrifuge at a speed of 700 rpm for 3 minutes.3- Blood is divided into three layers. A cell-free plasma, a middle section containing a fibrin clot, and a red section containing red blood cells at the bottom of the tube.4- PRF is drawn with a syringe.5- Then Eloderm is prepared in the same way as described in the previous group6- Now Alloderm with PRF will be mixed and fixed with periosteal sutures using 0-5 non-absorbable nylon suture material on the recipient site. Intervention group:In the ADM group, the acellular dermal matrix (AlloDerm®) will be prepared and applied according to the manufacturer's instructions. In summary:1- The membrane will be hydrated with 50 ml of sterile saline solution for 5 minutes.2- When the protective backing paper is removed, the ADM substance will be transferred to another container containing 50 ml of sterile serum solution and will be left there for 5 minutes.3- Then, the allograft will be cut to a size of one by two centimeters4- It will be fixed on the recipient site with periosteal sutures using 0-5 non-absorbable nylon suture material. Control group:For the control group:1. Taking a 1 to 2 mm thick FGG from the palate, depending on the amount of tissue in the palate of each patient and with dimensions of 1 x 1.5 cm2. Placement and fixation of FGG on the recipient surface with crossed sutures and non-absorbable sutures (Nylon 5.0, Ethilon®). Width of keratinized tissue around dental implants. Timepoint: Keratinized gingival width is achieved in patients 3 months after surgery. Method of measurement: A periodontal probe is used to measure the distance between the gingival margin and the mucogingival junction. The depth of the vestibule. Timepoint: 3 months after surgery. Method of measurement: The distance from the gingival margin to the deepest part of the vestibule. Kerman University of Medical Sciences Approved 2024-09-08 Ethics Committee of Kerman Medical Sciences shafa street dental school Kerman Kerman Iran (Islamic Republic of)