Evalution of Fixed Orthodontic Appliances on Salivary Changes in Vitamin C in Orthodontic Patients
Design
This study was randomized clinical trial and 30 patients were on this experiment for third time .once before bracing and then one month and three month after bracing , too see if we have salivary changes in vitamin C or not .
Settings and conduct
Faculty of Dentistry, Azad Islamic university of dental science in Tehran and one private orthodontic clinic in Tehran
Participants/Inclusion and exclusion criteria
Entry requirements: all of patients have to be in need for fixed orthodontic treatments and conditional of non-arrival were patients having lack of entry criterias for follow ups and having no cooperation
Intervention groups
The following measurements were done on all af the patients had criterias and entry requirement.
The totall number of patients were 30 .and they were third time on the experiments .once before bracing and then one month and three month later after bracing .the patients saliva were carried in plastic sample bottles to laboratory.
The Total number of samples was 90 .
and they were measured by Atomic Absorption Spectrophotometry .
Main outcome variables
Salivas vitamin C
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190109042308N1
Registration date:2019-10-14, 1398/07/22
Registration timing:retrospective
Last update:2019-10-14, 1398/07/22
Update count:0
Registration date
2019-10-14, 1398/07/22
Registrant information
Name
Sara Rousta
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 7814
Email address
dr.jahaniazadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-09-23, 1395/07/02
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
2017-06-25, 1396/04/04
Actual recruitment end date
2018-04-21, 1397/02/01
Trial completion date
2018-04-21, 1397/02/01
Scientific title
Evalution of Fixed Orthodontic Appliances on Salivary Changes in Vitamin C in Orthodontic Patients
Public title
The Effect of Fixed Orthodontic Appliances on Salivary Changes in Vitamin C in Orthodontic Patients
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria:
The patient should be in need of orthodontic treatment
The patient should be case of only fixed orthodontic treatment at the time of project
Exclusion criteria:
The patient that does not want to cooperate on the project
Age
From 12 years old to 38 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
90
Actual sample size reached:
90
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Faculty of Dentistry Islamic Azad University, Tehran Branch
Street address
Islamic Azad University, 9th neyestan ,pasdaran street,Tehran
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-06-18, 1396/03/28
Ethics committee reference number
IR.IAU.DENTAL.REC.1396.6
Health conditions studied
1
Description of health condition studied
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Vitamin c of saliva
Timepoint
Before bracing, one month and three months after bracing
Method of measurement
Atomic absorption spectrophotometry
Secondary outcomes
empty
Intervention groups
1
Description
To see how much do we have changes in mount of Vitamin C of saliva in patients with fixed orthodontic appliances . We had to give all the patients fixed orthodontic appliances such as aces/ligatures/wires. the examinations of saliva were before giving patients braces as primary amount of vitamin C in saliva,1 month after bracing ,and the last examination was on 3 month after bracing)
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthodontic Clinic in Islamic Azad University
Full name of responsible person
Dr. Ahmad Sheibani Nia
Street address
Islamic Azad University, Boostan 9 valley, Pasdaran street
City
tehran
Province
Tehran
Postal code
1969633651
Phone
+98 21 8877 7312
Fax
+98 21 8877 7312
Email
sararousta.d.d.s@gmail.com
Web page address
http://dental.iaumu.ac.ir
2
Recruitment center
Name of recruitment center
Valiasr Dental Clinic
Full name of responsible person
Dr. Azadeh Jahani
Street address
No. 2417, Valiasr street,Tehran
City
Tehran
Province
Tehran
Postal code
1517843315
Phone
+98 21 8888 7814
Fax
+98 21 8888 7814
Email
doctor.jahaniazadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ahmad Sheybani Nia
Street address
Islamic Azad University, Boostan 9 valley, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1969633651
Phone
+98 21 8877 7312
Email
Sararousta.d.d.s@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Sara rousta (researcher)
Proportion provided by this source
100
Public or private sector
Private
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
Islamic Azad University
Full name of responsible person
Dr Ahmad Shebani Nnia
Position
Orthodontic proffesor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Islamic Azad University, Boostan 9 valley, Pasdaran street
City
Tehran
Province
Tehran
Postal code
16677934783
Phone
+98 21 8877 7312
Fax
+98 21 8877 7312
Email
doctor.zahaniazadeh@gmail.com
Web page address
http://iau-tnb.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Ahmad Sheibani Nia
Position
University professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Islamic Azad University, Boostan 9 valley, Pasdaran street
City
Tehran
Province
Tehran
Postal code
1667934783
Phone
+98 21 8877 7312
Fax
+98 21 8877 7312
Email
doctor.zahaniazadeh@gmail.com
Web page address
http://iau-tnb.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Sara Rousta
Position
Dental student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
No3, Karimi ave, Gheytarie blvd., Tehran
City
Tehran
Province
Tehran
Postal code
1934943611
Phone
+98 21 2220 9990
Email
Sararousta.d.d.s@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
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
changing of salivas vitamin C
When the data will become available and for how long
1 year
To whom data/document is available
proffesores and students
Under which criteria data/document could be used
After defence and main presentation in university
From where data/document is obtainable
irct.ir and university site
What processes are involved for a request to access data/document