A comparison of white spot lesion prevention of ReminPro, CPP-ACP, MI Paste Plus and fluoride varnish in fixed orthodontic patients
Design
Randomized (random block method), Single-blind,without placebo-controlled , single arm trial. The sample size of this study is 100 individuals: divided into 5 groups of 20 people.
Settings and conduct
Private dentistry office.
Participants/Inclusion and exclusion criteria
Patients undergoing fixed orthodontic treatment in two jaws.
Inclusion criteria: Male and female in age range 12-35 years; no sensitivity to milk protein and benzovat preservers.
Exclusion criteria: Less than 6 months have remained to the end of orthodontic treatment; mental/physical disabilities; drug/alcohol addiction; systemic diseases; syndromic disorders.
Intervention groups
Control group: Toothbrush, Toothpaste, and Mouthwash
Intervention group 1: Toothbrush, Toothpaste, and Mouthwash + CPP-ACP
Intervention group 2: Toothbrush, Toothpaste, and Mouthwash + MI-Paste
Intervention group 3: toothbrush, toothpaste, and mouthwash + varnish fluoride
Intervention group 4: Toothbrush, toothpaste, and mouthwash + Remin pro
Main outcome variables
White spot lesion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170828035946N2
Registration date:2018-06-16, 1397/03/26
Registration timing:registered_while_recruiting
Last update:2018-06-16, 1397/03/26
Update count:0
Registration date
2018-06-16, 1397/03/26
Registrant information
Name
Sara Kaveh
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3333 4657
Email address
sara.kaveh@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Received fond of Semnan University of Mdical Sciences
Expected recruitment start date
2017-09-23, 1396/07/01
Expected recruitment end date
2018-07-21, 1397/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of white spot lesion prevention of ReminPro, CPP-ACP, MI Paste Plus and fluoride varnish in fixed orthodontic patients
Public title
A comparison of three different mineralization agents on initial tooth caries
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Male and female in age range 12-35 years
No sensitivity to milk protein and benzovat preservers
Exclusion criteria:
Less than 6 months is remained to the end of orthodontic treatment
Mental/physical disabilities
Drug/alcohol addiction
Systemic diseases
Syndromic disorders
Age
From 12 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization method: randomized blocks.
Random unit: Individual.
Randomization Tool: Table of random numbers.
Blinding (investigator's opinion)
Single blinded
Blinding description
Patients will be unaware of the treatment group and placebo.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Semnan University of Medical Sciences
Street address
5 km of Semnan-Mashhad road, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Approval date
2017-09-23, 1396/07/01
Ethics committee reference number
IR.SEMUMS.REC.1396.5
Health conditions studied
1
Description of health condition studied
White spot lesions
ICD-10 code
K02.8
ICD-10 code description
Other dental caries
Primary outcomes
1
Description
White spot lesion
Timepoint
2months
Method of measurement
Clinical observation based on ICDAS measure
Secondary outcomes
empty
Intervention groups
1
Description
Control group: Dental floss,Toothbrush, Toothpaste(Darougar Co.,Tehran,Iran) and Sodium Flouride 0.2% Mouthwash(Behsa Co.,Tehran,Iran) /flossing and tooth brushing twice a day and mouthwash twice a week
Category
Diagnosis
2
Description
Intervention group 1: Dental floss,Toothbrush, Toothpaste(Darougar Co.,Tehran,Iran.) plus CPP-ACP(GC tooth mousse,GC,Tokyo,Japan) /flossing and tooth brushing twice a day and tooth mousse once a night after brushig on teeth by a swab
Category
Treatment - Devices
3
Description
Intervention group 2: Dental floss, Toothbrush, Toothpaste(Darougar Co.,Tehran,Iran) plus CPP-ACPF(MI paste,GC,Tokyo,Japan) /flossing and tooth brushing twice a day and MI paste once a night after brushing on teeth by a swab
Category
Treatment - Devices
4
Description
Intervention group 3:Dental floss,Toothbrush, Toothpaste(Darougar Co.,Tehran,Iran) plus varnish fluoride(Duraflor ,Medicom, Canada)/flossing and tooth brushing twice a day and Fluoride varnish every 2 months
Category
Treatment - Devices
5
Description
Intervention group 4: Dental floss,Toothbrush, Toothpaste(Darougar Co.,Tehran,Iran) plus Remin pro(Voco, Cuxhaven, Germany)/flossing and tooth brushing twice a day and Remin pro once a night after brushing on teeth by a swab
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Private dental office
Full name of responsible person
Sara Kaveh
Street address
Shahrivar Blvd, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3346 1336
Email
sara.kaveh@semums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mohammadreza Asgari
Street address
Semnan University of Medical Sciences, Basij Boulevard, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3346 1336
Email
asgari5000@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Sara Kaveh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Saadi Square, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3346 1336
Fax
Email
sara.kaveh.ir@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sara Kaveh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Saadi Square, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3346 1336
Fax
Email
sara.kaveh.ir@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Sara Kaveh
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Faculty of Dentistry, Saadi Square, Semnan
City
Semnan
Province
Semnan
Postal code
3514799442
Phone
+98 23 3346 1336
Email
sara.kaveh.ir@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
-
When the data will become available and for how long
-
To whom data/document is available
Only available to scholars working in academic institutions.
Under which criteria data/document could be used
In case of relevant studies.
From where data/document is obtainable
Sara Kaveh, Shahrivar Blvd, Semnan, +98 933 380 0959
What processes are involved for a request to access data/document