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IRCT20101204005305N19 IRCT 2020-03-28 Kerman University of Medical Sciences evaluation of collagen membrane fixation with tack and suturing, and suturing alone in alveolar ridge augmentation Radiological and histological evaluation of collagen membrane fixation with tack and suturing, and suturing alone in horizontal alveolar ridge augmentation: A Randomized Clinical Trial 2019-09-11 anticipated 40 Complete https://irct.ir/trial/38904 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done using a coin toss and participants will be divided into intervention and control groups, Blinding description: Two clinicians who are calibrated and blind to the study will perform all radiographic measurements. The demographic data of all radiographies will be removed and a code will be given to each radiography. A pathologist who is blind to the study will assess the prepared slides. For blindness, a code will be given to each slides. 4 Bone loss. Intervention 1: Intervention group: collagen membrane fixation with tack and suturing after flap preparation. FDBA bone graft (Kish tissue replicator, Kish, Iran) placed in the surgical site then membrane (Kish tissue Corporation, Kish, Iran) stabilize with Vicryl suture (supa, Tehran, Iran) and tack. Soft tissue closure performs with nylon suture (supa,Tehran,Iran). Six months after the procedure, the implants will be inserted during the second surgery. Intervention 2: Control group: collagen membrane fixation with suturing alone after flap preparation. FDBA bone graft (Kish tissue replicator, Kish, Iran) placed in the surgical site then membrane (Kish tissue Corporation, Kish, Iran) stabilize with Vicryl suture (supa, Tehran, Iran). Soft tissue closure performs with nylon suture (supa,Tehran,Iran). Six months after the procedure, the implants will be inserted during the second 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 No more information
public mohammad mohammadi
Periodontics Department, Kerman Dental School, Shafa Street
Kerman Iran (Islamic Republic of) 7618759689 +98 34 1211 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 1211 9021 mmohammadi28@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) need to horizontal augmentation of alvolar bone for implant edentulous ridge width: 2/5-4 mm plaque index and bleeding index less than 20 percent. no limit no limit Both use of more than 10 cigarettes per day pregnancy uncontrolled periodontal diseases use of bisphosphonate and corticosteroid chemotherapy and radiotherapy systematic diseases for example: uncontrolled diabetes; osteoporosis and immune deficiency M85.8 Other specified disorders of bone density and structure Treatment - Surgery Treatment - Surgery Intervention group: collagen membrane fixation with tack and suturing after flap preparation. FDBA bone graft (Kish tissue replicator, Kish, Iran) placed in the surgical site then membrane (Kish tissue Corporation, Kish, Iran) stabilize with Vicryl suture (supa, Tehran, Iran) and tack. Soft tissue closure performs with nylon suture (supa,Tehran,Iran). Six months after the procedure, the implants will be inserted during the second surgery. Control group: collagen membrane fixation with suturing alone after flap preparation. FDBA bone graft (Kish tissue replicator, Kish, Iran) placed in the surgical site then membrane (Kish tissue Corporation, Kish, Iran) stabilize with Vicryl suture (supa, Tehran, Iran). Soft tissue closure performs with nylon suture (supa,Tehran,Iran). Six months after the procedure, the implants will be inserted during the second surgery. Alveolar Ridge Width. Timepoint: 6 month After bone augmentation. Method of measurement: By CBCT. Histology of new formed bone. Timepoint: 6 months after alveolar ridge augmentation. Method of measurement: Observation with optical microscope. Kerman University of Medical Sciences Approved 2019-08-25 Ethics Committee of Kerman Medical Sciences University Tahmasbabad Crossover, Researches Center Kerman Kerman Iran (Islamic Republic of)