Protocol summary
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Study aim
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Comparative study of the clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and cold ceramic in treating the pulp of mandibular second molars with reversible pulpitis.
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Design
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Parallel-group, double-blind, randomized, phase 2-3 clinical trial on 50 patients. A table of random numbers was used for randomization.
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Settings and conduct
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In children who refer to the pediatric dental clinic for treatment of pulp in mandibular second molar teeth with reversible pulpitis, after initial radiography, pulpotomy treatment is performed with a standard protocol. Pulp chamber seal is done for each patient using Mineral Trioxide Aggregate (MTA) or cold ceramic. then if there are no signs and symptoms of treatment failure, the final restoration is done with Stainless Steel Crown (SSC). Clinical evaluation of treatment results of 3, 6 and 12 months and radiographic evaluations are performed in 6 and 12 month periods. The patient and the evaluator of the treatment results will not know what substance was used to flood the canal in each patient
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Participants/Inclusion and exclusion criteria
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Patients who do not have any systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex, do not need general anesthesia and sedation, have good individual and family cooperation. deep caries with pulp exposure during caries removal.
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Intervention groups
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Intervention A: The remaining pulp is covered with paste MTA (cerkamed medical company poland ). Intervention B: The remaining pulp is covered with cold ceramic paste (Sarv Javaid modares, Iran).
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Main outcome variables
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The percentage of occurrence of pain; sensitivity to accuracy; swelling; pathological laziness; root lucency; internal or external root analysis; Widening of the Periodontal Ligament (PDL); bone loss; and lamina dura integrity
General information
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Reason for update
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According to endodontic and pediatric professors, reversible pulpitis is correct term.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230719058851N1
Registration date:
2023-07-27, 1402/05/05
Registration timing:
prospective
Last update:
2024-05-31, 1403/03/11
Update count:
3
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Registration date
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2023-07-27, 1402/05/05
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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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2023-08-06, 1402/05/15
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Expected recruitment end date
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2023-10-07, 1402/07/15
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molars with reversible pulpitis in 3-6 years old children: a randomized clinical trial
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Public title
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Evaluation of clinical and radiographic success and failure of Mineral Trioxide Aggregate (MTA) and Cold ceramic in pulp therapy of mandibular primary molars with reversible pulpitis in 3-6 years old children: a randomized clinical trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
The presence of two-thirds of the root length in terms of radiography; and lack of radiographic evidence of pulp degeneration, such as internal or external root resorption, furca radiolucency, intraradicular or periapical bone destruction, pulp stones.
Includes patients who have no systemic diseases such as congenital or rheumatic heart disease, leukemia, allergic reactions to substances such as local anesthetics and latex.
They have good individual and family cooperation, deep pitted lesions whose pulp is exposed during caries removal.
Exclusion criteria:
The presence of any clinical and radiographic symptoms indicating pulpal degeneration or physiological analysis of more than 2/3 of the root (imminence of tooth loss) non-physiological analysis of the root or possibility of proper tooth restoration.
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Age
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From 3 years old to 6 years old
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Gender
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Both
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Phase
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2-3
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Groups that have been masked
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- Participant
- Outcome assessor
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Sample size
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Target sample size:
50
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this study, a simple method using a table of random numbers will be used to randomly select people; In this way, first, the order "AB" is considered for the odd number, and the order "BA" is considered for the even number. Then we refer to the table, choose a column randomly and if the first selected number is odd, we use the order 'AB'; In this way, the first person in group A will receive Mineral Trioxide Aggregate treatment and the next person will receive cold ceramic treatment spontaneously in group B. In the same way, if the number obtained is even, consider the order of BA and the first person will be placed in group B and receive cold ceramic treatment, and the next person will automatically be placed in group A and receive Mineral Trioxide Aggregate treatment. This work is repeated for 25 times to get 25 samples in each group.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Clinical and radiographic evaluations are performed by a person who does not know the type of substance used in each group. - The patient will not know the type of material used in each tooth.
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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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2023-07-17, 1402/04/26
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Ethics committee reference number
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IR.MEDILAM.REC.1402.111
Health conditions studied
1
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Description of health condition studied
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Mandibular molars reversible pulpitis
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ICD-10 code
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K04.0
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ICD-10 code description
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Pulpitis
Primary outcomes
1
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Description
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Frequency of pain in treated molars
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Timepoint
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3,6 and 12 months after treatment
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Method of measurement
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The history of the presence or absence of spontaneous pain after the treatment is asked from the patient. (Yes/No)
2
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Description
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The frequency of occurrence of sensitivity to dex in treated primary molars
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Timepoint
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3,6 and 12 months after treatment
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Method of measurement
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During a clinical examination with a precision test, the patient is asked if there is any sensitivity or not
3
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Description
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The frequency of occurrence swelling in treated primary molars
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Timepoint
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3,6 and 12 months after treatment
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Method of measurement
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A clinical examination is performed to detect the presence or absence of swelling
4
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Description
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The frequency of occurrence fistula in treated primary molars
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Timepoint
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3,6 and 12 months after treatment
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Method of measurement
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A clinical examination is performed to detect the presence or absence of fistula.
5
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Description
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The frequency of occurrence pathologic mobility in treated primary molars
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Timepoint
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3,6 and 12 months after treatment
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Method of measurement
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A clinical examination is performed to detect the presence or absence of pathologic mobility.
6
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Description
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The frequency of occurrence of root lucency in radiographic images in treated primary molars
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Timepoint
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6 and 12 month after treatment
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Method of measurement
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Radiographic examination is performed to detect the presence or absence of lucency around the root
7
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Description
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The frequency of occurrence of internal resorbtion in radiographic images in treated primary molars
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Timepoint
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6 and 12 month after treatment
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Method of measurement
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Radiographic examination is performed to detect the presence or absence of internal resorbtion
8
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Description
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The frequency of occurrence of external resorbtion in radiographic images in treated primary molars
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Timepoint
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6 and 12 month after treatment
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Method of measurement
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Radiographic examination is performed to detect the presence or absence of external resorbtion
9
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Description
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The frequency of occurrence of PDL widening in radiographic images in treated primary molars
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Timepoint
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6 and 12 month after treatment
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Method of measurement
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Radiographic examination is performed to detect the presence or absence of PDL widening
10
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Description
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The frequency of occurrence of bone resorbtion in radiographic images in treated primary molars
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Timepoint
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6 and 12 month after treatment
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Method of measurement
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Radiographic examination is performed to detect the presence or absence of bone resorbtion
11
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Description
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The frequency of occurrence of lamina dura disintegration in radiographic images in treated primary molars
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Timepoint
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6 and 12 month after treatment
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Method of measurement
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Radiographic examination is performed to detect the presence or absence of lamina dura disintegration
Intervention groups
1
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Description
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Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with two millimeters of paste (cerkamed Medical Company Poland) MTA+. which will be obtained by mixing the powder with sterile saline at a ratio of 3:1 and is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth.
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Category
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Treatment - Other
2
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Description
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Intervention group B : Intervention group A:First, a periapical radiograph will be prepared from the desired tooth using the standard parallel technique with the help of Rinne xcp (dentsply, USA). Film number zero is used with speed E (Kodak, Ekta speed) or speed F (Kodak, Insigne). Then appropriate local anesthesia is performed using lidocaine 2% and epinephrine 1:80000 (Darou pakhsh, Tehran, Iran) and then the surface of the tooth is primed with chlorhexidine 0.2% (Shahre Daru, Tehran, Iran) and the coronal caries are removed by providing isolation with rubberdam under sterile conditions and with an Angle No. 4 burr.In the next step, the roof of the pulp chamber is removed with a 330 high speed bur along with water spray and the coronal access hole is completed. Using a large process bur (No. 6), the coronal pulp is completely removed from the entrance of the canals and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the site of coronal pulp excision, on the entrance of the canals, using a sterile cotton ball moistened with normal saline within 5 minutes (2,3,5). If homeostasis is not achieved, the patient is excluded from the study. The remaining pulp is covered with three millimeters of paste cold ceramic is covered. A layer of zonalin (Golchadent company) is temporarily placed and the patient is visited again seven days later (short term follow up). Before placing the Stainless Steel Crown (SSC), the operator first checks the clinical signs, pain, sensitivity to impact, swelling, laxity and fistula. In the absence of the mentioned cases, the tooth will be repaired with SSC. The patient will not know the type of material used in each tooth.
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Category
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Treatment - Other
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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Ilam 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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Yes - There is 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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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All data will be shareable
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When the data will become available and for how long
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Access period 6 months after publication of results
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To whom data/document is available
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Researchers working in academic and scientific institutions
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Under which criteria data/document could be used
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No other conditions are required
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From where data/document is obtainable
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Contact via mail : faezeazizi96@gmail.com
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What processes are involved for a request to access data/document
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As soon as the request is received, the documents will be provided to the requester within a week
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Comments
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