comparison of motivation, expectation, satisfaction and treatment efficiency between patients treat with clear aligner and patients treat with fixed orthodontic
Comparison of motivation, expectation, satisfaction and treatment efficiency between patients treat with clear aligner and patients treat with fixed orthodontic
Design
This is a non-blinded clinical trial. The study population will be all patients referred to the orthodontics department of Kermanshah school of dentistry .40 eligible patients will be selected conveniently and randomly assigned to two intervention groups.
Settings and conduct
This study which will be conducted in the Kermanshah school of dentistry is a non-blinded one. Patients will complete the motivation, expectation, satisfaction, and Patients will complete the motivation, expectation, satisfaction, and efficacy questionnaire before starting the study. efficacy questionnaire before starting the study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients who do not need tooth extraction for treatment
Intervention groups
The first intervention group will receive fixed orthodontic treatment. The second intervention group will receive clearer aligner treatment.
Main outcome variables
Satisfaction, treatment efficiency
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20130812014333N130
Registration date:2019-11-25, 1398/09/04
Registration timing:registered_while_recruiting
Last update:2019-11-25, 1398/09/04
Update count:0
Registration date
2019-11-25, 1398/09/04
Registrant information
Name
Feizollah Foroughi
Name of organization / entity
kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1821 4653
Email address
fforoughi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-06, 1398/08/15
Expected recruitment end date
2019-12-06, 1398/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
comparison of motivation, expectation, satisfaction and treatment efficiency between patients treat with clear aligner and patients treat with fixed orthodontic
Public title
comparison of motivation, expectation, satisfaction and treatment efficiency between patients treat with clear aligner and patients treat with fixed orthodontic
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with moderate need for orthodontics
Informed consent
Exclusion criteria:
Patients who do not need tooth extraction for treatment
Patients who need beauty supplies
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Individual randomization method using random number table through code reception.40similar cards will be provided which 20 of them are coded 1 which is indicative of the first intervention group, and 20 of them are coded 2 which is indicative of the second intervention group. Anyone who is eligible for inclusion in the study will select one of these cards randomly.
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 Kermanshah University of Medical Sciences
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-10-15, 1398/07/23
Ethics committee reference number
ir.kums.rec.1398.696
Health conditions studied
1
Description of health condition studied
Satisfaction from orthodontic
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
satisfaction
Timepoint
After the end of the study
Method of measurement
Based on the Patient Satisfaction Questionnaire
2
Description
treatment efficiency
Timepoint
Before the study and one month after the study
Method of measurement
Based on the Oral Impact on Daily Performance Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group will receive constant orthodontic treatment.
Category
Treatment - Other
2
Description
The second intervention group will receive clearer orthodontic treatment.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Farhad Mahmoud Nader
Street address
Shariati Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
dentistfarhad222@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Farid Najafi
Street address
Building No.2, Shahid Beheshti, Vice Chancellor for Research Affairs, Kermanshah University of Medical Sciences
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3836 0014
Email
fnajafi@kums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Faarhad Mahmoud Nader
Position
Student of dental
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shariati Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
dentistfarhad222@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Dr. Amin Golshah
Position
Member of Kermanshah University of Medical Sciences
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shariati Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
amin.golshah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farhad Mahmoud Nader
Position
Student of dental
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Shariati Street, Faculty of Dentistry
City
Kermanshah
Province
Kermanshah
Postal code
6713954658
Phone
+98 83 3729 6591
Email
dentistfarhad222@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The main outcomes of the study will be shared.
When the data will become available and for how long
6 month
To whom data/document is available
If requested, results will be made available to other academic researchers
Under which criteria data/document could be used
Collected data is confidential and will not be shared with anyone else
From where data/document is obtainable
To receive the documentation, email send for update manager
What processes are involved for a request to access data/document
In a 25-day period, the documents will be sent e-mail