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Comparision of tooth alignment and pain perception of different sizes of nickle-titanium archwires in the initial phase of fixed orthodontic treatment : randomized clinical trial

Protocol summary

Summary
This study is a double-blinded randomized clinical trial and will be conducted on patients attending comprehensive orthodontic treatment. 81 patients will be included in this study. The patients will be randomly allocated into 3 groups of 27 patients, each receiving a 0.012 inch superelastic NITI archwire (Highland Metals, USA), 0.014 inch superelastic NITI archwire (Highland Metals, USA), 0.016 inch superelastic NITI archwire(Highland Metals, USA) as initial archwire. After placement of brackets( 0.022 inch slot, Roth system),initial archwires will be inserted in each group by elastomeric O'rings (American Orthodontics, USA). The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10. .the data will be analyzed by SPSS 21. At first, quantative statistical parameters will be calculated in each group and then mixed factorial ANOVA test will be used for comparison of pain amount in different intervals in three groups.if there will be significant difference, post hoc test will be used for comparison of different intervals. p<0.05 will be cosidered significant.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016042427577N1
Registration date: 2017-04-12, 1396/01/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-04-12, 1396/01/23
Registrant information
Name
Aydin Sohrabi
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3330 9214
Email address
asohrabi@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2018-03-21, 1397/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision of tooth alignment and pain perception of different sizes of nickle-titanium archwires in the initial phase of fixed orthodontic treatment : randomized clinical trial
Public title
Comparision of tooth alignment and pain perception of different sizes of nickle-titanium archwires in the initial phase of fixed orthodontic treatment : randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: presence of all permanant teeth except third molars; no quadhelix or other palatal expansion device present; no extraoral appliance; no deep overbite; no use of NSAIDS before study. Exclusion criteria: pervious orthodontic treatment; medical history or craniofacial abnormality; active periodontal disease; skeletal asymmetry; systemic diseases that might affect pain perception, or in therapy for pain conditions; previous incisor extraction; missing of incisors or canine; unwillingness of patient; vertical displacement of incisors more than 3 mm; tooth block out due to crowding.
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 81
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht street, Azadi street
City
Tabriz
Postal code
Approval date
2017-01-01, 1395/10/12
Ethics committee reference number
IR.TBZMED.REC.1395.1039

Health conditions studied

1

Description of health condition studied
tooth alignment
ICD-10 code
z00-z99
ICD-10 code description
factors influencing health status and contact with health service

Primary outcomes

1

Description
Tooth alignment
Timepoint
4, 8, 12 weeks after arch wire substitution
Method of measurement
Caliper/ 0.01 mm

2

Description
Pain level
Timepoint
Immedietly, 4, 24 and 72 hours after
Method of measurement
Standard questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
After placement of brackets( 0.022 inch slot, Roth system),0.012 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in first interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10.
Category
Treatment - Devices

2

Description
After placement of brackets( 0.022 inch slot, Roth system),0.014 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in second interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10.
Category
Treatment - Devices

3

Description
After placement of brackets( 0.022 inch slot, Roth system),0.016 inch nickle titanium archwires will be inserted by elastomeric O'rings (American Orthodontics, USA) in third interventional group. The method of O'rings insertion will be dependant on clinician's judgement. The variables of the study will be the amount of tooth alignment and pain peception after insertion of initial archwires. At the begining of study and before placement of brackets, impression will be taken and stone casts will be prepared to calculate the amount of irregularity index (Little's irregularity index) and vertical discrepency by digital caliper (at 0.01mm). At 4,8 and 12 weeks intervals, impressions will be taken again and the amount of irregularity index (Little's irregularity index) and vertical discrepency will be calculated. The amount of pain will be documented in each interval. The amount of pain will be evaluated subjectively using visual analogue scale.patients will be asked to determine pain severity by drawing a vertical line on the horizontal line of questionare and determine a number from 0 to 10.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Private Clinic
Full name of responsible person
Dr. Aydin Sohrabi(orthodontist-associate professor)
Street address
Kaj building, Shariati intersection
City
Tabriz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Full name of responsible person
Mohammadreza Rashidi
Street address
3d floor , No 2 Central Building, Tabriz University of Medical Sciences, Golgasht Street, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research (VCR) of Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aydin Sorabi
Position
Orthodontist/ associated professor
Other areas of specialty/work
Street address
Tabriz Dentistry Faculty, Golgasht street, Aazadi street
City
Tabriz
Postal code
5165687386
Phone
+98 41 3330 9214
Fax
Email
ay_sorabi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aydin Sohrabi
Position
Orthodontist/ associated professor
Other areas of specialty/work
Street address
Tabriz University of Medical Sciences
City
Tabriz
Postal code
5165687386
Phone
+98 41 3330 9214
Fax
Email
ay_sohrabi@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Aydin Sohrabi
Position
Orthodontist/ associated professor
Other areas of specialty/work
Street address
Tabriz Dentistry Faculty, Golgasht street, Aazadi street
City
Tabriz
Postal code
5157711111
Phone
+98 41 3330 9214
Fax
Email
ay_sohrabi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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