Determinaton of effects of fixed orthodontic treatment together with Chlorhexidine mouth wash on the vitality of cells of oral mucosa in vivo.
Design
In this research 30 patients undergoing orthodontic treatment are indicated. Participants should have orthodontic treatment.Sampling is done by scrubing oral mucosa ,before beginning of treatment, One month later and two weeks after that using mouth rins in patients with gingivitis. Study is done in-vivo condition. Patients sign Consent Form.
Settings and conduct
This study was performed in orthodentic department of Islamic Azad University Dental Branch of Tehran.Sampling is done by scrubing oral mucosa ,before beginning of treatment, One month later and two weeks after that using mouth rins in patients with gingivitis. Study is done in-vivo condition. Patients sign Consent Form.
Participants/Inclusion and exclusion criteria
Inclusion criteria : Have a indication for fixed orthodontics treatment for both jawsn Exclusion criteria:age rang 12-35 years ;No systemic disease ;No use cigarette and alcohol ;No previous experience of orthodontic treatment ;Using mouth rinse with gingivitis.
Intervention groups
In this study, Chlorhexidine is as a intervention.This mouth wash is used to reduce inflammation of the gum and has not been specifically prescribed for it
Main outcome variables
Vitality of cells of oral mucosa.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20161205031250N3
Registration date:2017-12-25, 1396/10/04
Registration timing:retrospective
Last update:2017-12-25, 1396/10/04
Update count:0
Registration date
2017-12-25, 1396/10/04
Registrant information
Name
Fariborz Amini
Name of organization / entity
Islamic Azad University Of Medical Sciense Dental School
Country
Iran (Islamic Republic of)
Phone
+98 21 2212 1619
Email address
f_amini@dentaliau.ac.ir
Recruitment status
Recruitment complete
Funding source
Personal experiences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2017-10-23, 1396/08/01
Actual recruitment start date
2017-08-23, 1396/06/01
Actual recruitment end date
2017-11-06, 1396/08/15
Trial completion date
empty
Scientific title
Evaluation of the effect of fixed orthodontic devices with using Chlorhexidin mouth rins on vitality of oral mocusa cells in clinical conditions.
Public title
Effect using chlorhexidin on oral mocusa.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who indication for fixed orthodontics treatment for both jaws
In age rang 12-35 years
Exclusion criteria:
No systemic disease
No use cigarette and alcohol
No previous experience of orthodontic treatment
Using mouth rinse with gingivitis
Age
From 12 years old to 40 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
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
Ethic committee of Islamic Azad University Dental Branch of Tehran
Street address
No.4, Neyestan 9.,Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Approval date
2017-05-22, 1396/03/01
Ethics committee reference number
IR-IAU.DENTAL.REC.1395,27
Health conditions studied
1
Description of health condition studied
Patients with Fixed Orthodontics Appliance
ICD-10 code
Z46.4
ICD-10 code description
Primary outcomes
1
Description
Vitality of Oral mocousal cell
Timepoint
Befor treatment ,1 month after treatment and 2 weeks after treatment
Method of measurement
Number of cells with microscope
Secondary outcomes
empty
Intervention groups
1
Description
Patients use CHX Mouthwash 0/012% BID for 30 seconds for 2 weeks after 1 month of Orthodontic treatment.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Orthodontics , Islamic Azad University Dental Branch of Tehran
Full name of responsible person
Mahyar Mahvash Mohammadi
Street address
NO.4, Neyestan 9.,Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2218 1566
Email
mahyar.mahvash@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research Islamic Azad University Dental Branch of Tehran
Full name of responsible person
mahyar mahvash mohammadi
Street address
No.4,Neyestan 9.,Pasdaran Ave.
City
Tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2218 1566
Email
Mahyar.Mahvash@yahoo.com
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 Islamic Azad University Dental Branch of Tehran
Proportion provided by this source
1
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
Department of Orthodontics, Faculty of Dentistry , Islamic Azad University of Tehran
Full name of responsible person
Mahyar Mahvash Mohammadie
Position
Post graduate student of orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
Orthodentics
Street address
No.4 , Neyastan 9.,Pasdaran Ave
City
tehran
Province
Tehran
Postal code
19585175
Phone
+98 21 2256 4573
Fax
Email
Mahyar.mahvash@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Faculty of Dentistry , Islamic Azad University of Tehran
Full name of responsible person
Dr Fariborz Amini
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Orthodontics
Street address
No.4,Neyestan 9.,Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
19515875
Phone
+98 21 2333 4467
Fax
Email
F_amini@dentaliau.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University Dental Branch of Tehran
Full name of responsible person
Mahyar Mahvash Mohammadi
Position
Post graduat student of Orthodontics
Latest degree
Medical doctor
Other areas of specialty/work
orthodontics
Street address
No.4,Neyestan 9.,Pasdaran Ave
City
Tehran
Province
Tehran
Postal code
1987954551
Phone
+98 21 2218 1566
Fax
+98 21 2218 1566
Email
Mahyar.Mahvash@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available