Protocol summary
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Study aim
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Evaluate relationship between orthodontic tooth movement and root development
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Design
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In this study, 32 patients indicated for fixed orthodontic treatment considering inclusion criteria will be selected. Second premolar teeth in both sides of mandible enter to case and control group by random table.
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Settings and conduct
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This study will be performed in a professional dental clinic in Tehran city center and one of private offices in Tehran. Before treatment, a primary PA radiography of second premolar of both sides will provided, then braces will applied to all teeth (experimental second premolar) except second premolar in one side of mandible (control) which will be selected randomized. After 9 months, the second PA radiography of second premolar of both sides will be provided. Then the brace will applied to second premolar in opposite side (control). In this time, experimental and control teeth are bonded and are under orthodontic movement. The duration of this split mouth study is 9 months. Patients and researchers was blind and this study is double blind.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria consists of existence of second premolars in both sides of mandible, indicated for fixed orthodontics and malocclusion Class I, anterior crowding and posterior mild crowding, no dental caries and crown or root anomalies before treatment. Exclusion criteria consists of dilaceration of dental roots other dental developmental anomalies.
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Intervention groups
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The intervention will performed by applying orthodontic force by the Roth Bracket system with a 0.22 slot is performed on one of the second premolars.
The other second premolar is a control tooth that is not under orthodontic movement.
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Main outcome variables
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root resorption or apposition
General information
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Reason for update
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20170928036471N1
Registration date:
2017-12-13, 1396/09/22
Registration timing:
registered_while_recruiting
Last update:
2018-01-19, 1396/10/29
Update count:
1
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Registration date
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2017-12-13, 1396/09/22
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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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Dentofacial Deformities Research Center, Research Institute of Dental Sciences, Dental School, Shahid Beheshti University of Medical Sciences
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Expected recruitment start date
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2017-12-01, 1396/09/10
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Expected recruitment end date
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2018-03-01, 1396/12/10
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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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Root length evaluation after orthodontic treatment in immature teeth
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Public title
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Root length evaluation after orthodontic treatment in immature teeth
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Existence of immature second mandibular premolar in both sides of mandible
Indication of fixed orthodontic treatment
Class I malocclusion
mild crowding in posterior region of mandible
Exclusion criteria:
Dilaceration of roots
other dental developmental anomalies
dental caries in premolars
Absence of dental crown anomalies
Absence of dental root anomalies
moderate or severe crowding in posterior region of mandible
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Age
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From 10 years old to 15 years old
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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
- Investigator
- Outcome assessor
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Sample size
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Target sample size:
32
More than 1 sample in each individual
Number of samples in each individual:
2
Second premolar teeth in both sides of mandible that one side act as case group and other side act as control group by random.
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Randomization method: simple randomization
Randomization tool: randomization table
random allocation to second premolars in right and left side of mandible for determination of case or control 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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The patients don't know that second premolar of which side of mandible get braces.
The researcher and the person who measure the root length changes don't know that second premolar of which side of mandible was under orthodontic force because the periapical radiography of second premolars before treatment has no evidence of braces and also after 8 months before taking radiography of second premolars, the control tooth get brace. So nether in first periapical radiography not in second one, it is not clear that which second premolar was under force. In other hand it is not clear which tooth is in case group or control group.
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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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2015-02-16, 1393/11/27
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Ethics committee reference number
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IR.SBMU.RIOS.REC.1396.457
Health conditions studied
1
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Description of health condition studied
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Orthodontic care and follow up
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ICD-10 code
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z46.4
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ICD-10 code description
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Fitting and adjustment of orthodontic device
Primary outcomes
1
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Description
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Dental root length
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Timepoint
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before intervention, 9 months after intervention
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Method of measurement
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by using photoshop software and evalute the digital periapical radiography
Intervention groups
1
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Description
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Intervention 1:apply orthodontic force on second premolar of one side of mandible by a Roth bracket system with a 0.22 slot from American Orthodontics productions, for 9 months.
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Category
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Treatment - Other
2
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Description
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Intervention 1:Routine care
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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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مركز تحقيقات ناهنجاری های دندانی فكی دندان پزشکی شهید بهشتی تهران
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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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be 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