Protocol summary
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Study aim
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Comparative evaluation of of MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis
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Design
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A parallel-group, double-blind, randomized, phase 2-3 clinical trial on 58 patients. A table of random numbers was used for randomization.
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Settings and conduct
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In children refer to the specialized children's office in Ilam city for pulp therapy in mandibular primary molar teeth with reversible pulpitis, after preparing the initial radiograph and pulpotomy, the remaining pulp is covered for each patient with using Mineral Trioxide Aggregate (MTA) or Biodentine. After one week, if there are no signs and symptoms of treatment failure, the final restoration is done with Stainless Steel Crown. Clinical evaluation of treatment results at 3, 6, 9, and 12 months and radiographic evaluations are performed at 6- and 12-month periods. The patient and the evaluator of the treatment results will not know what substance was used.
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Participants/Inclusion and exclusion criteria
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- Inclusion criteria: patients without any systemic diseases, allergic reactions, do not need general anesthesia and sedation, good cooperation, Deep cavity lesions with vital pulp exposure, no history of spontaneous or nocturnal pain; Absence of clinical signs such as swelling; The presence of two-thirds of the root length radiographically; and lack of radiographic evidence of pulp degeneration
-Exclusion criteria: lack of parental consent to participate in the study, teeth that could not be SSC.
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Intervention groups
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Intervention A: The remaining pulp is covered with paste MTA.
Intervention B: The remaining pulp is covered with paste Biodentine.
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Main outcome variables
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the percentage of occurrence of pain; sensitivity to precussion; swelling; fistula; pathological mobility; root lucency; internal or external root resorption; Widening of the Periodontal Ligament; bone loss; and lack of 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 the correct term.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20230718058836N1
Registration date:
2023-07-22, 1402/04/31
Registration timing:
prospective
Last update:
2024-05-14, 1403/02/25
Update count:
2
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Registration date
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2023-07-22, 1402/04/31
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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 Biodentine in pulp therapy of mandibular primary molar 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 MTA and Biodentine in pulp therapy of mandibular primary molar with reversible pulpitis
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Initial inclusion criteria include 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 cavity lesions whose pulp is exposed during caries removal and are vital, no history of spontaneous or nocturnal pain; Absence of clinical signs such as swelling, fistula, sensitivity to precussion or palpation, pathological mobility; teeth in which hemostasis is achieved within 5 minutes during the clinical procedure; The presence of two-thirds of the root length radiographically; and lack of radiographic evidence of pulp degeneration, such as internal or external root resorption, furca radiolucency, intraradicular or periapical bone destruction, pulp stones.
Exclusion criteria:
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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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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:
58
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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 random number tables will be used to 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 MTA treatment and the next person will receive Biodentine treatment spontaneously in group B. In the same way, if the obtained number is even, the "BA" order is taken into consideration and the first person is placed in group B and receives Biodentine treatment, and the next person is automatically placed in group A and receives MTA treatment. This work is repeated for 29 times to obtain 29 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 consumed 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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2023-07-15, 1402/04/24
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Ethics committee reference number
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IR.MEDILAM.REC.1402.110
Health conditions studied
1
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Description of health condition studied
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Irreversible pulpitis of mandibular primary molar
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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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The frequency of pain in sealed primary molars
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Timepoint
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Three, six, nine and 12 months after treatment
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Method of measurement
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The patient is asked about the presence or absence of spontaneous pain after treatment (yes/no).
2
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Description
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The percentage of frequency of occurrence of tooth sensitivity to pecussion in sealed primary molars
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Timepoint
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Three, six, nine and 12 months after treatment
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Method of measurement
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During a clinical examination with a precussion 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 swelling in sealed primary molars
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Timepoint
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Three, six, nine 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 percentage of frequency of occurrence of fistula in sealed primary molars
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Timepoint
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Three, six, nine 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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Frequency of occurrence of pathological mobility in sealed primary molars
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Timepoint
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Three, six, nine 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 pathological mobility.
6
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Description
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The frequency of occurrence of root lucency in radiographic images in sealed primary molars
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Timepoint
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Six and 12 months 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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Frequency of internal resortion in radiographic images of sealed primary molars
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Timepoint
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Six and 12 months 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 root resorption.
8
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Description
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The percentage of occurrence of root external resorption in radiographic images of sealed primary molars
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Timepoint
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Six and 12 months 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 resorption of the root
9
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Description
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The frequency of occurrence of PDL widening in the radiographic images of sealed primary molars
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Timepoint
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Six and 12 months 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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Frequency percentage of bone loss in radiographic images of sealed primary molars
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Timepoint
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Six and 12 months 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 loss.
11
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Description
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Frequency of lamina dura non-integrity in radiographic images of sealed primary molars
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Timepoint
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Six and 12 months 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 integrity
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 first local anesthesia with lidocaine 2% and epinephrine (Daropakhsh/Iran) 1:80000 is performed. The decayed crown is removed under sterile conditions using a rubberdam and a No. 4 round slow-speed bur, and in the next step, the roof of the pulp chamber is removed with a 330 high-speed bur along with water, and access to the crown will be completed. Using process bur No. 6, the crown pulp is completely removed from the entrance of the canal and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the coronal pulp excision site at the entrance of the canals using sterile cotton moistened with normal saline for 5 minutes. If hemostasis does not occur, the tooth is excluded from the study. In group A, the remaining pulp is covered with 2 mm of MTA paste (at a ratio of 3 to 1). 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 symptoms, pain, sensitivity to precussion, swelling, mobility 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: 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 first local anesthesia with lidocaine 2% and epinephrine (Daropakhsh/Iran) 1:80000 is performed. The decayed crown is removed under sterile conditions using a rubberdam and a No. 4 round slow-speed bur, and in the next step, the roof of the pulp chamber is removed with a 330 high-speed bur along with water, and access to the crown will be completed. Using process bur No. 6, the crown pulp is completely removed from the entrance of the canal and the pulp chamber is washed with normal saline. Hemostasis will be achieved at the coronal pulp excision site at the entrance of the canals using sterile cotton moistened with normal saline for 5 minutes. If hemostasis does not occur, the tooth is excluded from the study. In group B, the remaining pulp is covered with 2 mm of Biodentine paste. 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 symptoms, pain, sensitivity to precussion, swelling, mobility 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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Yes - There is 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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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be 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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The access period starts 6 months after the results are published.
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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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Send email to the address pardis.sahraj@hotmail.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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