Evaluation of the effect of Nano-hydroxyapatite on White Spot lesions in orthodontic patient
Design
In this study, 25 participant will recieve toothpastes contain nano-hydroxyapatite and 25 person will recive non -nano-hydroxyapatite toothpastes. They should be taken twice daily for 6 months.
Settings and conduct
This study will be conducted at the orthodontics department of Shahid Beheshti Dental School and with the consent of the participants
Participants/Inclusion and exclusion criteria
The orthodontic treatment will be finish
exit:bad oral hygiene
Intervention groups
The participants will be given a toothpaste to use for six months, either with or without a nano-hydroxyapatite that is randomly selected.
Main outcome variables
Toth remineralization
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180928041162N1
Registration date:2018-11-10, 1397/08/19
Registration timing:registered_while_recruiting
Last update:2018-11-10, 1397/08/19
Update count:0
Registration date
2018-11-10, 1397/08/19
Registrant information
Name
Nima Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 4422 2717
Email address
nima_igt@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-02-28, 1396/12/09
Expected recruitment end date
2018-12-30, 1397/10/09
Actual recruitment start date
2018-08-09, 1397/05/18
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of the effect of Nanohydroxyapatite on White Spot lesions in orthodontic patient
Public title
Evaluation of the effect of Nanohydroxyapatite on White Spot lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Finishing the orthodontic treatment
Compliance with oral hygiene
Exclusion criteria:
Bad oral hygiene
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
50
Actual sample size reached:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Participants are divided to two group and each group receive one tothpaste that is blind to us belongs to that group
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study nobody knows about wich tothpaste is the main tothpaste and that is the usuall tothpaste except manufacturing factory
Placebo
Not used
Assignment
Parallel
Other design features
.......
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Velenjac.daneshjo blv
City
tehran
Province
Tehran
Postal code
1983963113
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.485
2
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Velenjac.daneshjo blv
City
TEHRAN
Province
Tehran
Postal code
1983963113
Approval date
2017-07-31, 1396/05/09
Ethics committee reference number
IR.SBMU.RIDS.REC.1396.485
Health conditions studied
1
Description of health condition studied
Whitespot lesion
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Enamel remineralizasion
Timepoint
0-1-3-6 month after using tothpaste
Method of measurement
Diagnodent؛photography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: using tothpaste for 6 month
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid beheshti orthodontic department
Full name of responsible person
Asghar ebadifar
Street address
Velenjac ,daneshjo blv
City
Tehran
Province
Tehran
Postal code
4371733661
Phone
+98 13 4422 2717
Email
nima_igt@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
اصغر عبادی فر
Street address
VELENJAC.DANESHJO BLV
City
TEHRAN
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
NIMA_IGT@YAHOO.COM
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
10
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
2
Sponsor
Name of organization / entity
Shahid beheshti dentofacial deformities reserch center
Full name of responsible person
Asghar ebadi far
Street address
Velenjac. daneshjo blv
City
tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2241 3897
Email
Reserch.ids@sbmu.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid beheshti dentofacial deformities reserch center
Proportion provided by this source
90
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asghar ebadifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjo blv
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2240 3075
Email
Nima_igt@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Asghar ebadifar
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Daneshjo blv
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2242 3075
Email
Nima_igt@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima jafari
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Daneshjo blv
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 13 4422 2717
Email
Nima_igt@yahoo.com
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
Yes - There is a plan to make this available
Statistical Analysis Plan
No - There is not 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
A portion of the data that does not contain the personal information of the participants will be published
When the data will become available and for how long
Release of the data will be one year after print the results
To whom data/document is available
Researchers and industry workers can use this study
Under which criteria data/document could be used
It is safe to use this data with mention the source of the this information
From where data/document is obtainable
Asghar ebadifar0 tehran velenjak daneshjo blv. orthodontic department of shahid beheshti dental school 1983963113
tel:02122403075
What processes are involved for a request to access data/document