to compare canine retraction and anchorage loss rate using NiTi closed coil spring and elastomeric power chains in maxillary first premolar extraction cases
Study will be performed prospectively at department of orthodontics, Shahid Beheshti University of medical sciences, Tehran, Iran. Following alignment and leveling, a maxillary dental cast will be taken. Four months after canine retraction, another cast will be taken. Amount of canine movement during this period will be calculated. Outcome assessment will be performed by a calibrated orthodontist who is blind to the intervention group.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
• Generally healthy patients
• Age 13 to 25 years
• needed maxillary first premolar extraction as a part of orthodontic treatment
• Straight wire fixed orthodontic appliance
• No anchorage control or inter-arch elastic was indicated at the first 4 months of treatment
• All permanent teeth were present and erupted (not considering 2nd and 3rd molars)
Exclusion criteria:
• Systemic disease that could influence tooth movement
• Taking medication that could influence tooth movement
• Craniofacial syndromes
• Pregnancy
Intervention groups
First orthodontic brackets will be placed on maxillary teeth. Then, first premolars of the maxilla will be extracted and orthodontic alignment and leveling of the teeth will be done. Following placement of 19*25 stainless steel wire, extraction space closure using frictional mechanics will be initiated. At this stage, each maxillary canine will be randomly retracted using elastomeric chain (American Orthodontics) on one side of the mouth and 9 mm NiTi closed coil spring (American Orthodontics) on the other side of the mouth.
Main outcome variables
Canine retraction rate
anchorage loss rate (First molar movement)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161126031100N1
Registration date:2019-03-09, 1397/12/18
Registration timing:retrospective
Last update:2019-03-09, 1397/12/18
Update count:0
Registration date
2019-03-09, 1397/12/18
Registrant information
Name
Saeed Reza Motamedian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2240 8071
Email address
motamedian@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-01, 1396/07/09
Expected recruitment end date
2018-02-28, 1396/12/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of canine retraction and anchorage loss rate by NiTi coils versus elastomeric chains: A randomized split-mouth study
Public title
Comparison of two canine retraction methods
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Generally healthy patients
Age 13 to 25 years
Needed maxillary first premolar extraction as a part of orthodontic treatment
Straight wire fixed orthodontic appliance
No anchorage control or inter-arch elastic was indicated at the first 4 months of treatment
All permanent teeth were present and erupted (not considering 2nd and 3rd molars)
Exclusion criteria:
Systemic disease that could influence tooth movement
Taking medication that could influence tooth movement
Craniofacial syndromes
Pregnancy
Age
From 13 years old to 25 years old
Gender
Both
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
Maxillary canine retraction rate on the left and right sides of the mouth
Randomization (investigator's opinion)
Randomized
Randomization description
Each method will be used on one side which was selected randomly for each patient. The first half of the patients will be randomized to the treatment sequence A-B and the other half to the treatment sequence B-A (A: elastomeric chain and B: NiTi coil)
Blinding (investigator's opinion)
Single blinded
Blinding description
All measurements will be performed by a calibrated orthodontist who is blind to the retraction method. Also, statistical analysis will be performed by an expert who is blind to the type of intervention.
Placebo
Not used
Assignment
Other
Other design features
Split mouth
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Shahid Beheshti University of Medical Sciences
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
19813
Approval date
2018-10-14, 1397/07/22
Ethics committee reference number
IR.SBMU.DRC.REC.1397.022
Health conditions studied
1
Description of health condition studied
Malocclusion
ICD-10 code
K07.3
ICD-10 code description
Anomalies of tooth position
Primary outcomes
1
Description
Canine retraction rate
Timepoint
Before intervention, 4 months after intervention
Method of measurement
The distance between canine cusp tip and the line connection first rugae will be measured on occlusograms using a digital caliper. This amount will be divided to 4 to show canine retraction rate per month.
Secondary outcomes
1
Description
Anchorage loss
Timepoint
before intervention and 4 months after intervention
Method of measurement
The distance between mesiobuccal cusp of first molar and the line connection first rugae will be measured on occlusograms using a digital caliper. This amount will be divided to 4 to show anchorage loss rate per month.
Intervention groups
1
Description
Intervention group: Amount of canine retraction on one side of the maxilla using 9 mm NiTi closed coil (American Orthodontics) with 200 grams force during 4 months.
Category
Treatment - Devices
2
Description
Intervention group: Amount of canine retraction on one side of the maxilla using elastomeric chain (American Orthodontics) with 200 grams force during 4 months.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Depratment of orthodontics, Shahid Beheshti university of medical sciences
Full name of responsible person
Saeed Reza Motamedian
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
13819
Phone
+98 21 2240 8071
Email
sr.motamedian@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Azita Tehranchi
Street address
Velenjak, School of Dentistry, Shahid Behehshti University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
19813
Phone
+98 21 2240 8071
Email
sr.motamedian@yahoo.com
Grant name
School of Dentistry, Shahid Beheshti university of medical sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Reza Motamedian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
19813
Phone
+98 21 2240 8071
Email
sr.motamedian@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Reza Motamedian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
19813
Phone
+98 21 2240 8071
Email
sr.motamedian@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Saeed Reza Motamedian
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Velenjak
City
Tehran
Province
Tehran
Postal code
19813
Phone
+98 21 2240 8071
Email
sr.motamedian@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Amount of canine movement per month for each patient and for each technique
Amount of first molar movement per month for each patient and for each technique
When the data will become available and for how long
starting immediately after publication
To whom data/document is available
This will be only available for people working in academic institutions.
Under which criteria data/document could be used
Non-comercial use
From where data/document is obtainable
Email: sr.motamedian@yahoo.com
What processes are involved for a request to access data/document
1- Sending request email including the purpose of using data and your personal information
2- Data will be sent in one week