Clinical and radiographic evaluation of the progression of the proximal enamel caries in the molars after resin infiltrations compared with tooth mousse.
Clinical and radiographic results of progression of proximal enamel caries in children's molars after infiltration resin compared to tooth mousse
Design
Randomized clinical trial
Settings and conduct
The study is carried out at the Faculty of Dentistry, University of Tehran.
Participants/Inclusion and exclusion criteria
Children with at least two molar caries can be included in the study and children with systemic diseases or noncommunicable do not qualify for inclusion.
Intervention groups
One is the molar group where the resin is applied and the other is the paste.
Main outcome variables
This study can be used to prevent the progression of proximal caries if it is found that infiltration resin and tooth mousse paste treatments have significant effects on preventing the progression of proximal caries lesions.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20191015045114N1
Registration date:2020-03-15, 1398/12/25
Registration timing:registered_while_recruiting
Last update:2020-03-15, 1398/12/25
Update count:0
Registration date
2020-03-15, 1398/12/25
Registrant information
Name
mona mansourvar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2272 3340
Email address
ghazalebaniebrahimi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-02-20, 1398/12/01
Expected recruitment end date
2020-07-22, 1399/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical and radiographic evaluation of the progression of the proximal enamel caries in the molars after resin infiltrations compared with tooth mousse.
Public title
Clinical and radiographic evaluation of the progression of the proximal enamel caries in the molars after resin infiltrations compared with tooth mousse.
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria:
Children with at least two of the molars with enamel caries.
Exclusion criteria:
Caries that have become cavities.
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
Children with at least two of the molars with enamel caries.
Randomization (investigator's opinion)
N/A
Randomization description
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
Iran national committee for ethics in biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
tehran
Province
Tehran
Postal code
1467664961
Approval date
2019-08-07, 1398/05/16
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.100
Health conditions studied
1
Description of health condition studied
Clincal and radiographic evaluation of the progression of the proximal enamel careis in the molars after resin infiltrations compared with tooth mousse
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
enamel caries
Timepoint
At baseline and one, three, six months thereafter
Method of measurement
Clinical and radiographic measurements
Secondary outcomes
1
Description
Stop enamel caries
Timepoint
At baseline and one, three, six months thereafter
Method of measurement
Clinical and radiographic measurements
Intervention groups
1
Description
Intervention group 1: Moles on which resin is applied.Resin is a treatment infiltration that is performed by the dentist to prevent the caries from progressing. The treatment is performed once and the approximate duration of application of the resin is 5 minutes.
Category
Prevention
2
Description
Intervention group: Moles on which the paste is applied. tooth mousse should be used once daily to prevent the caries from progressing.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry, University of Tehran
Full name of responsible person
Ghazale Baniebrahimi
Street address
Mahan street, Khani abad no, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1988644458
Phone
+98 21 2272 3340
Email
ghazalebaniebrahimi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazale Baniebrahimi
Street address
Mahan street, Khani abadno, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1988644458
Phone
+98 21 2272 3340
Email
ghazalebaniebrahimi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Ghazale Baniebrahimi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mahan street, Khani abadno, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1988644458
Phone
+98 21 2272 3340
Email
ghazalebaniebrahimi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazaleh Baniebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Afra Complex , Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 2272 3340
Email
ghazalebaniebrahimi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ghazale Baniebrahimi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Afra Complex , Tajrish Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
Phone
+98 21 2272 3340
Email
ghazalebaniebrahimi@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Part of the data, such as information about the main outcome or the like
When the data will become available and for how long
Access started several months after the study was completed and the results reviewed
To whom data/document is available
Everyone can take action
Under which criteria data/document could be used
No conditions
From where data/document is obtainable
Department of Pediatrics, Faculty of Dentistry, University of Tehran
What processes are involved for a request to access data/document