Protocol summary
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Study aim
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Histological and radiological comparison of FDBA with and without autogenous bone graft and collagen membrane for horizontal augmentation of alveolar bone
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Design
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A randomized controlled clinical trial, parallel groups, single blind, Intervention group: Using of FDBA plus autogenous bone to augment alveolar ridge horizontally Control group: Using FDBA alone
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Settings and conduct
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This study will be done in Kerman Dental School. After flap elevation, in intervention group FDBA plus autogenous bone and collagen membrane and in control group, FDBA and collagen membrane will be used and then flap will be sutured. Two clinicians who are calibrated will perform the radiographic measurements. A code will be given to each radiography for blindness. A pathologist will assess the slides. A code will be given to each slide for blindness
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Participants/Inclusion and exclusion criteria
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Patients of Kerman University of Medical Sciences. Inclusion criteria: need to horizontal augmentation of alvolar bone for implant (edentulous ridge width: 2/5 - 4 mm and in B-W group) Exclusion criteria: contraindications for implant treatment (use of more than 10 cigarettes per day pregnancy; non controlled periodontal diseases; use of bisphosphonate and corticosteroid; chemotherapy and radiotherapy; systematic diseases for example: non controlled diabetes; osteoporosis and immune deficiency)
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Intervention groups
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Intervention group: Using of FDBA plus autogenous bone to augment alveolar ridge horizontally Control group: Using FDBA alone
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Main outcome variables
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ٌWidth of alveolar ridge
General information
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Reason for update
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sample size increased to 42 patients
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT201109165305N3
Registration date:
2017-06-25, 1396/04/04
Registration timing:
registered_while_recruiting
Last update:
2020-03-31, 1399/01/12
Update count:
1
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Registration date
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2017-06-25, 1396/04/04
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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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Kerman dental and oral diseases research, vice chancellor for research, Kerman university of medical sciences
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Expected recruitment start date
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2017-01-20, 1395/11/01
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Expected recruitment end date
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2017-04-21, 1396/02/01
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Actual recruitment start date
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2017-05-12, 1396/02/22
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Actual recruitment end date
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2018-01-07, 1396/10/17
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Trial completion date
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2018-04-06, 1397/01/17
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Scientific title
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Comparison of histological and radiological effect of FDBA with and without autogenous bone graft with collagen membrane in horizontal augmentation of alveolar bone
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Public title
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Comparison of tow different bone grafts for horizontal graft of alveolar bone
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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
non controlled periodontal diseases
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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Sample size
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Target sample size:
42
Actual sample size reached:
42
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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minimization ; At the beginning, participants will be distributed in two groups with throwing coin, then researcher select and distribute the participants in regard to the main inclusion criteria and the sex to balance the groups
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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All radiographic measurements will be done by two clinicians who will be calibrated. Demographic information for each radiography will be deleted and a code was given to each of them. Pathologic assessment will be performed by a pathologist with giving code to each prepared slide.
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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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2017-05-03, 1396/02/13
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Ethics committee reference number
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IR.KMU.REC.1396.1098
Health conditions studied
1
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Description of health condition studied
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Bone loss
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ICD-10 code
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M85.8
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ICD-10 code description
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Other specified disorders of bone density and structure
Primary outcomes
1
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Description
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Horizontal dimension of alveolar ridge
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Timepoint
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6 month after insert the implants
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Method of measurement
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By CBCT
Secondary outcomes
1
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Description
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Histology of new formed bone
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Timepoint
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6 months after insert the implants
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Method of measurement
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Observation with optical microscope
Intervention groups
1
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Description
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Intervention: Bone graft surgery of alveolar ridge with freezed dried bone allograft {1000-2000 microns granules (Kish tissue regeneration, Kish, Iran) and autogenous bone graft from ramus or chin of patient' own, with 1:1 proportion.
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Category
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Treatment - Surgery
2
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Description
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Control: Bone graft surgery of alveolar ridge with freezed dried bone allograft {1000-2000 microns granules (Kish tissue regeneration, Kish, Iran) alone.
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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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Vice Chancellor for Research, Kerman University of Medical Science
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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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No - There is not 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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Data file
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When the data will become available and for how long
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2020-2021
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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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