The comparison of pain perception and compliance of orthodontic patients treated with heavy and medium intermaxillary elastics
Design
A randomized clinical trial using random numbers table, two parallel groups and 53 patients in each group, without blindness
Settings and conduct
The elastics will be placed from the canine tooth to the first molar. Patients in the first group will receive medium elastic and patients in the second group will receive heavy elastic. Patients' pain intensity will be recorded on the same day, one, four, and fourteen days after receiving intermaxillary elastics by using the visual analog scale. A researcher-made questionnaire will be used based on Likert scale to measure patient compliance.
Participants/Inclusion and exclusion criteria
Inclusion criteria is to have the consent to participate in the study. Exclusion criteria is to have systemic or mental illness and addiction to alcohol or any psychoactive substance.
Intervention groups
This study has two groups. Patients in the first group will be treated with medium intermaxillary elastic and the second group will be treated with heavy intermaxillary elastic.
Main outcome variables
Pain intensity; Patient compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150628022951N5
Registration date:2018-05-21, 1397/02/31
Registration timing:registered_while_recruiting
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
milad Ghanizadeh
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3335 5921
Email address
milad.ghanizadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-07-11, 1397/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of pain perception and compliance of orthodontic patients treated with heavy and medium intermaxillary elastics
Public title
The comparison of pain perception and compliance of patients treated with orthodontic elastics
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the consent to participate in the study
Exclusion criteria:
Having a systemic or mental disease
Addiction to alcohol or any psychoactive substance
Age
From 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
106
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a simple randomization method will be used. Each person will be assigned a code, and according to the random number table, each person will be placed in a group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2018-03-01, 1396/12/10
Ethics committee reference number
IR.TBZMED.REC.1397.106
Health conditions studied
1
Description of health condition studied
Jaw discrepancy
ICD-10 code
K07.1
ICD-10 code description
Anomalies of jaw-cranial base relationship
Primary outcomes
1
Description
Pain intensity
Timepoint
on the same day, one, four, and fourteen days after receiving intermaxillary elastic
Method of measurement
Visual analog scale
Secondary outcomes
1
Description
Patient compliance
Timepoint
on the same day, one, four, and fourteen days after receiving intermaxillary elastic
Method of measurement
Researcher-made questionnaire
Intervention groups
1
Description
First intervention group: Receiving medium intermaxillary elastic
Category
Treatment - Devices
2
Description
Second intervention group: Receiving heavy intermaxillary elastic
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Tabriz Dental Faculty
Full name of responsible person
Zahra Mardani
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
z_mardani422@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Abolgasem Joyban
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
researchteam.tbzmed@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Ali Rafigi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
rafighi_ali@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Mardani
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Fax
+98 41 3335 9680
Email
z_mardani422@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Rafigi
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht Avenue, Azadi Street,Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4658
Email
rafighi_ali@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Demographic information of patients and data related to the outcomes of the study (pain intensity and patient compliance) will be shared.
When the data will become available and for how long
The access period starts 6 months after the results are published.
To whom data/document is available
Researchers working in academic and scientific institutions
Under which criteria data/document could be used
Sharing data for meta-analysis
From where data/document is obtainable
Please contact Dr. Zahra Mardani by e-mail:
z_mardani422@yahoo.com
What processes are involved for a request to access data/document
After ensuring that your claim is true, these data will be sent to you.