Comparison of the effect of fluoride varnish with silver diamine fluoride on oral pH in the period of primary teeth in children with Sever-Early Childhood Caries (S-ECC)
Determining the effect of silver diamine fluoride on oral pH
Determining the effect of fluoride varnish on oral pH
Comparison of the effect of silver diamine fluoride and fluoride varnish on oral pH
Design
A clinical trial study with a control group
Fluoride varnish group (control group) silver diamine fluoride group (intervention group)
Samples will be assigned to two random groups using the random number generation method by Random Number Generator software. In this way, random numbers in the range (0,1) will be generated in the software and numbers less than 0.5 will be assigned to the silver diamine fluoride group and numbers greater than 0.5 to the Fluoride varnish group (and vice versa). These two substances will be purchased from Pooyesh Teb Atieh Company.
Settings and conduct
In this clinical trial study that will be performed in a private office and clinic in Zanjan, a number of children are divided into two groups: fluoride varnish and silver diamine fluoride.
Participants/Inclusion and exclusion criteria
Inclusion criteria: The child should be between 2 and 4 years old (have a deciduous tooth system in the age range), have a complication of premature tooth decay, the patient's parents should cooperate well and be aware of the side effects of silver diamine fluoride.
Exclusion criteria: The child has any systemic disease, any mental disability, herpes and herpes and dry mouth.
Intervention groups
The first group is given 5% fluoride varnish (V-varnish / Korea / fluoride varnish / 0.4 ml) under the brand name V-varnish.
For the second group, 30% silver diamine fluoride (SDF) (cariestop30% / Iran / biodinamica / ml5) is used.
Main outcome variables
Immediately after SDF application, 5 minutes later, after 10 minutes, after 20 minutes, and after 30 minutes, oral pH was measured and recorded using paper.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210718051926N1
Registration date:2021-08-15, 1400/05/24
Registration timing:prospective
Last update:2021-08-15, 1400/05/24
Update count:0
Registration date
2021-08-15, 1400/05/24
Registrant information
Name
bahareh nazemi salman
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 24 3341 2597
Email address
dr.b.nazemi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-20, 1400/05/29
Expected recruitment end date
2021-09-15, 1400/06/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effect of fluoride varnish with silver diamine fluoride on oral pH in the period of primary teeth in children with Sever-Early Childhood Caries (S-ECC)
Public title
pH in children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
patients without systemic disease
Severe early childhood caries (sECC)
Exclusion criteria:
parents forbidden
Age
From 2 years old to 4 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
38
Randomization (investigator's opinion)
Randomized
Randomization description
Samples will be assigned to two random groups using the random number generation method by Random Number Generator software. In this way, random numbers in the range (0,1) will be generated in the software and numbers less than 0.5 will be assigned to the SDF group and numbers greater than 0.5 to the NaF group (and vice versa).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of zanjan university of medical sciences
Street address
Zanjan university of medical sciences ,gavazang ave, zanjan town
City
Zanjan
Province
Zanjan
Postal code
۴۵۱۵۶۱۳۱۹۱
Approval date
2021-07-24, 1400/05/02
Ethics committee reference number
IR.ZUMS.REC.1400.145
Health conditions studied
1
Description of health condition studied
dental caries
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
oral pH
Timepoint
0-5-10-20-30 minutes after intervention
Method of measurement
pH-indicator paper
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Silver diamine fluoride will be used once. Then at 5, 10, 20 and 30 minutes after the intervention, children's oral pH will be measured using pH paper.
Category
Prevention
2
Description
Control group: fluoride varnish will be used once. Then at 5, 10, 20 and 30 minutes after the intervention, children's oral pH will be measured using pH paper.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Pediatric dentistry center
Full name of responsible person
Bahareh Nazemi Salman
Street address
Aftab buliding, Ghalee Ave, Zanjan
City
Zanjan
Province
Zanjan
Postal code
7854329003
Phone
+98 24 3341 2597
Email
dr.b.nazemi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Alireza Shoghli
Street address
Central building of Zanjan university of medical sciences, Jomhori eslami Blvd, Zanjan
City
Zanjan
Province
Zanjan
Postal code
9876675432
Phone
+98 24 3315 6141
Email
shoghli@zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
Bahareh Nazemi Salman
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Zanjan university of medical sciences, Mahdavi Blvd, Mahdavi Ave
City
Zanjan
Province
Zanjan
Postal code
7698654327
Phone
+98 24 3341 2597
Email
dr.b.nazemi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Bahareh Nazemi salman
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Zanjan university of medical sciences, Mahdavi Blvd, Mahdavi Ave
City
Zanjan
Province
Zanjan
Postal code
4513813657
Phone
+98 24 3341 2597
Fax
Email
dr.b.nazemi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Bahareh Nazemi salman
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Zanjan university of medical sciences, Mahdavi Blvd, Mahdavi Ave
City
Zanjan
Province
Zanjan
Postal code
4513813657
Phone
+98 24 3341 2597
Fax
Email
dr.b.nazemi@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
The complete data file includes personal information such as gender and age and study information such as the type of intervention and the measured outcomes of the final outcome.
When the data will become available and for how long
The results and the resulting article can be shared immediately after publication.
To whom data/document is available
All people
Under which criteria data/document could be used
Mentioning the source and the city and the people who did the work, any analysis is allowed.
What processes are involved for a request to access data/document
In case of phone call or e-mail and explaining the reason for requesting the data and guarantee for future reference, the data will be sent at the earliest opportunity. Of course, provided that the preliminary results are published