Protocol summary
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Study aim
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histomorphometrical and radiological comparison of mineralized allogeneic bone graft with or without iPRF in the reconstruction of horizontal alveolar ridge defects
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Design
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A double-blind randomized clinical trial on 40 patients with a control group and parallel groups. Randomization will be done with minimization method.
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Settings and conduct
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Kerman university of medical science; faculty of dentistry
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Participants/Inclusion and exclusion criteria
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The study population includes patients who refer to the School of Dentistry of Kerman University of Medical Sciences. These patients have a B-W edentulous ridge (width 2.5-4 mm) and need horizontal bone aggregation to perform implant treatment. According to similar studies and the limited number of patients who meet the inclusion criteria, the sample size is 20 patients who are divided into two groups of test (using FDBA and iPRF) and control (using FDBA).
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Intervention groups
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Intervention group: In this group, FDBA and iPRF are used in the reconstruction of horizontal ridge defects.
Control group: In this group, FDBA alone is used to regenerate these lesions.
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Main outcome variables
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Ridge width change in CBCT view, inflammatory markers in histological view
General information
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Reason for update
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Increase the sample size
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20101204005305N20
Registration date:
2022-02-16, 1400/11/27
Registration timing:
prospective
Last update:
2022-11-23, 1401/09/02
Update count:
2
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Registration date
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2022-02-16, 1400/11/27
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2021-10-23, 1400/08/01
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Expected recruitment end date
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2022-04-19, 1401/01/30
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Actual recruitment start date
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2022-02-20, 1400/12/01
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Actual recruitment end date
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2022-09-21, 1401/06/30
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Trial completion date
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empty
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Scientific title
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Histomorphometrical and radiological comparison of mineralized allogeneic bone graft with or without L-PRF in the reconstruction of horizontal alveolar ridge defects in a randomized controlled clinical trial.
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Public title
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Comparison of two methods using mineralized allogeneic bone graft with or without iPRF in the reconstruction of horizontal alveolar ridge defects.
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
need to horizontal augmentation of alvolar bone for implant treatment (edentulous ridge width: 2/5 - 4 mm )
Exclusion criteria:
Use of more than 10 cigarettes per day
Pregnancy
Uncontrolled periodontal disease
Use of bisphosphonate and corticosteroid
Chemotherapy and radiotherapy
Systematic diseases for example: non controlled diabetes; osteoporosis and immune deficiency
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Participant
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
20
Actual sample size reached:
41
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization will be done with the minimization method. Randomization of 10 to 20 percent of the samples will be done in a simple way by tossing a coin, and then the participants will be divided into two intervention groups and control groups based on their gender in order to homogenize the groups.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2021-09-06, 1400/06/15
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Ethics committee reference number
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IR.KMU.REC.1400.335
Health conditions studied
1
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Description of health condition studied
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Edentulous ridge width
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Horizontal edentulous ridge width
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Timepoint
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Measurement of edentulous ridge width by CT scan of the patient at the beginning of the study and 6 months after reconstructive surgery
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Method of measurement
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Bone width measurement from CBCT radiograph
Intervention groups
1
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Description
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Control group: First a mid-crystal incision is made and then vertical release incisions with a gap tooth on each side to increase access. The flap is removed in full-thikness. Decoration is done. From Freeze Dried Bone Allogrft 0 granules2000-1000 microns. Kish texture replicator, Kish, Iran) is used. The bone marrow is moistened with sterile saline solution before use. After placement of the target area, it is completely covered by absorbable collagen membrane (thickness 0.4 to 0.6 microns. Kish tissue replicator, Kish, Iran). The membranes are fixed on the membranes by absorbable vicryl sutures (supa, Tehran, Iran) using the horizontal scrubber technique. Soft tissue closure is initially done with Supa, Iran (Supalon, 5-0) nylon sutures with 3 techniques: Horizontal mattress, interrupted and crisscross. 6 months after the agglomeration process, the implants are placed during the second surgery.
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Category
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Treatment - Surgery
2
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Description
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Intervention group: First, blood is taken from the patient's cephalic vein and centrifugation is performed on it to inject platelet rich fibrin. Then, in the operation stage, a mid-crystal incision is made and then the vertical releasing incisions are struck with a gap tooth on each side to increase. The flap is removed in full-thikness. Decoration is done. From Freeze Dried Bone Allogrft 0 granules2000-1000 microns. Kish texture replicator, Kish, Iran) is used with iPRF. The affected bone is moistened with sterile saline solution before use. After placing the desired area, it is completely covered by an absorbable collagen membrane (thickness 0.4 to 0.6 microns. Kish, Kish, Iran) tissue replicator. The membranes are fixed on the membranes by absorbable vicryl sutures (supa, Tehran, Iran) using the horizontal scrubber technique. The closure of the soft tissue is initially done with Supalon, Iran (Supalon 5-0) nylon sutures and with 3 horizontal mattress techniques, cut and crossed. 6 months after the agglomeration process, the implants are placed during the second operation.
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Category
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Treatment - Surgery
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Kerman University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Not applicable
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Data Dictionary
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No - There is not a plan to make this available
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Title and more details about the data/document
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Part of the data is shared after the people are made unrecognizable.
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When the data will become available and for how long
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2023-2024
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To whom data/document is available
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Academic persons
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Under which criteria data/document could be used
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No special access criteria
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From where data/document is obtainable
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E-mail:mmohammadi28@yhoo.com
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What processes are involved for a request to access data/document
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There are not details
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Comments
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