Protocol summary
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Study aim
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Evaluating the color changes for four different brands of elastic ligatures within patient's mouths: Ortho Technology, Ortho Organizers, American Orthodontics, and Manufacturing Orthodontics.
Informing and providing feedback for patients of the color-changing patterns of ligatures with interest in athletics and clear ligatures.
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Design
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A clinical trial with parallel and Triple-blind groups was performed on 54 patients
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Settings and conduct
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we performed the sampling in three orthodontist offices located in the Kianpars region in the city of Ahwaz. patients and orthodontist specialists were not aware of which brands they were receiving. Every brand was placed in a jaw quarter on tooth numbers 1 to 3, such that all four brands were inside the patients' mouths simultaneously. On the day of placement and also four weeks after the placement, we measure the color changes by consulting with patients, orthodontists, as well as photography and Photoshop software.
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Participants/Inclusion and exclusion criteria
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Patients are accepted with no pre-existing birth-related defects with at least six teeth in upper and lower jaw.
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Intervention groups
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The use of ligatures in fixed orthodontic treatment and without any change in the time and process of treatment of patients, only 4 brands were used to evaluate the degree of change in the elastic color of the ligatures.
First intervention : elastic ligatures from Ortho Technology (U.S.A) Were placed in patient's mouths for the duration of four weeks
Second : elastic ligatures from Ortho Organizers (U.S.A) Were placed in patient's mouths for the duration of four weeks
Third: elastic ligatures from Manufacturer Orthodontic (Italy) Were placed in patient's mouths for the duration of four weeks
Fourth: elastic ligatures from American Orthodontics (Germany) Were placed in patient's mouths for the duration of four
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Main outcome variables
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Color changes
General information
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Reason for update
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Instead of the code of ethics, the research project number was incorrectly entered, which was corrected in this update.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200815048409N1
Registration date:
2020-10-03, 1399/07/12
Registration timing:
retrospective
Last update:
2020-10-08, 1399/07/17
Update count:
1
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Registration date
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2020-10-03, 1399/07/12
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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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2020-08-24, 1399/06/03
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Expected recruitment end date
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2020-10-01, 1399/07/10
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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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A Comparison of color changes Between Four Different ligature brands: Ortho Technology and Ortho Organizers and American Orthodontics and Orthodontic Manufacturer - in Vivo Study
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Public title
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A Comparison of Color Changes in Elastic Ligatures - in Vivo Study
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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Inclusion criteria:
The Existence of at least 6 teeth in upper and lower jaw.
Exclusion criteria:
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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
- Care provider
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
54
More than 1 sample in each individual
Number of samples in each individual:
12
Insertion of three different ligature brands in each jaw quarter.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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We assigned a number to each brand of ligatures Ortho technology:1 Ortho Organizers:2 Orthodontic Manofactory:3 and American Orthodontics:4. Then We randomly selected a number between 1 to 4 and placed a brand in each quarter of the patients jaw based on the random number.
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Blinding (investigator's opinion)
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Triple blinded
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Blinding description
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The selection of brand for each ligature for each patient, orthodontist, and data analyst is blind.
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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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2020-01-22, 1398/11/02
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Ethics committee reference number
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IR.AJUMS.REC.1398.694
Health conditions studied
1
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Description of health condition studied
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Evaluation of color changes for four different ligature brands: Ortho Technology and Ortho Organizers and American Orthodontics and Manufacturer orthodontic
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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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Measuring the color changes of ligature in range of 1-4 with photography and softwares such as PhotoShop and CIE-LAB
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Timepoint
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At the beginning of the study and after 4 weeks.
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Method of measurement
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Questionnaire and photography
Intervention groups
1
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Description
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First intervention group: elastic ligatures from Ortho Technology (U.S.A) Were placed in patient's mouths for the duration of four weeks(28 days).
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Category
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Other
2
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Description
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Intervention group Second : elastic ligatures from Ortho Organizers (U.S.A) Were placed in patient's mouths for the duration of four weeks(28 days).
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Category
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N/A
3
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Description
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Intervention group Third: elastic ligatures from Manufacturer Orthodontic (Italy) Were placed in patient's mouths for the duration of four weeks(28days).
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Category
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N/A
4
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Description
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Intervention group Fourth: elastic ligatures from American Orthodontics (Germany) Were placed in patient's mouths for the duration of four weeks(28 days).
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Category
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N/A
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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Ahvaz 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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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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Data can be shared in a way to keep the privacy of participants.
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When the data will become available and for how long
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Access can be started y the end of Year 1399
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To whom data/document is available
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Data can be accessible for professionals active in academia, industry, and orthodontic patients.
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Under which criteria data/document could be used
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We do not foresee any limitation for accessing this research's data.
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From where data/document is obtainable
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Please contact me through my email:
sara.gholamian100@gmail.com or my cell: +989166007221
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What processes are involved for a request to access data/document
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Requests for accessing data can be made directly through my email.
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Comments
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