Protocol summary

Study aim
Comparing the effect of fluoride varnish with silver diamine fluoride on oral pH in pediatric deciduous teeth
Design
Clinical trial with two groups in parallel, not blind, randomized, Excel software rand function was used for randomization
Settings and conduct
In this study, which is performed in the pediatric ward of Tehran Dental School, all samples should be brushed without prophylaxis paste before any work so that plaque is removed and dental surfaces are free of debris. Immediately after brushing, PH The mouth is marked with pH meter paper and its number is recorded.Working conditions are the same for all samples and all tests are performed by one person, and for all samples, cotton roll and suction are used to establish isolation and standardize the conditions.
Participants/Inclusion and exclusion criteria
Admission requirements: The child should be between 5 and 7 years old, The child should not have any systemic disease, should not have any mental disability, patient cooperation should be good, understand Persian language, should not have herpes And herpes and no dry mouth.Exclusion criteria: The child has a systemic disease or dry mouth, mental disability, herpes and herpes, does not understand Persian and his cooperation is low.
Intervention groups
In this study, in order to evaluate the effectiveness of silver diamine fluoride (SDF) on the pH of the mouth of children with deciduous dental system and compare it with fluoride varnish, the samples were divided into two groups and to the first group after isolation, fluoride varnish was applied on The teeth and the pH of the mouth was assessed at various times. For the second group, SDF was applied after isolation and oral pH was measured at 5 times.
Main outcome variables
The rate of change in oral pH

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200727048218N1
Registration date: 2020-11-23, 1399/09/03
Registration timing: retrospective

Last update: 2020-11-23, 1399/09/03
Update count: 0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Sara Akbari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2625 5095
Email address
minaakbari316@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-24, 1398/10/03
Expected recruitment end date
2020-01-25, 1398/11/05
Actual recruitment start date
2019-12-24, 1398/10/03
Actual recruitment end date
2020-01-23, 1398/11/03
Trial completion date
2020-01-23, 1398/11/03
Scientific title
Comparison of the effect of fluoride varnish with silver diamine fluoride on oral pH in the period of primary teeth
Public title
Comparison of the effect of fluoride varnish with silver diamine fluoride on children's teeth
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Understand Persian language The patient should be between 5 and 7 years old
Exclusion criteria:
The child have any systemic disease The child has any mental disability Patient cooperation is not good Do not understand Persian language Have herpes The child have xerostomia The child's dental system is mixed dentition
Age
From 5 years old to 7 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
Actual sample size reached: 18
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are divided into two equal groups using randomization with six random blocks with the help of Excel software. In each block, three samples are placed in group A and three samples in group B and the randomization process is studied by the methodology consultant. Done and researchers are conceal of it.
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
Ethics committee of Tehran University of Medical Sciences
Street address
Dibaji jonubi St,Rahmani St,Negin dibaji complex,No5
City
Tehran
Province
Tehran
Postal code
1918799913
Approval date
2019-12-10, 1398/09/19
Ethics committee reference number
IR.TUMS.DENTISTRY.REC.1398.159

Health conditions studied

1

Description of health condition studied
PH of children's mouths
ICD-10 code
ICD-10 code description

2

Description of health condition studied
Silver diamine fluoride
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The pH of children's mouths
Timepoint
Immediately after treatment, then 5 minutes later, after 10 minutes, after 20 minutes and after 30 minutes using pH paper, oral pH is measured and recorded
Method of measurement
By pH paper

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: The samples are randomly divided into two groups and the first group is given 5% fluoride varnish (V-varnish / Korea / fluoride varnish / 0.4 ml) with V-varnish brand. Immediately after fluoride varnishing, then 5 minutes later, after 10 minutes, after 20 minutes and after 30 minutes using oral pH meter paper, the pH of the mouth is measured and recorded.
Category
Prevention

2

Description
Intervention group: For the second group, silver diamine fluoride 30% (SDF) (cariestop30% / Iran / biodinamica / ml5) is used. Immediately after SDF application, 5 minutes later, after 10 minutes, after 20 minutes, and after 30 minutes, the pH of the mouth is measured and recorded using pH meter paper.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran university of dentistry
Full name of responsible person
Sara Akbari Masouleh
Street address
Dibahi jonubi St,Rahmani St,Negin dibaji complex,No5
City
Tehran
Province
Tehran
Postal code
1918799913
Phone
+98 21 2625 5095
Email
minaakbari316@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Marzieh Alikhasi
Street address
North Kargar Street, adjacent to the Atomic Energy Organization, Tehran Universityl of Dentistry
City
Tehran
Province
Tehran
Postal code
1918799913
Phone
+98 21 8801 5881
Email
dent-research@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Tehran university of medical science
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
Donya alinejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No.5,Negin dibaji Complex,Gholamreza Rahmani St,Dibaji jonubi Ave
City
Tehran
Province
Tehran
Postal code
1918799913
Phone
+98 21 2625 5095
Email
minaakbari316@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Donya Alinejad
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No 5,Gholamreza Rahmani St,Dibaji Jonubi Ave
City
Tehran
Province
Tehran
Postal code
1918799913
Phone
+98 21 2625 5095
Email
saraakbarim268@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sara Akbari
Position
ُStudent
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
No 5,Gholamreza Rahmani St, Dibaji Jonubi Ave.
City
Tehran
Province
Tehran
Postal code
1918799913
Phone
+98 21 2625 5095
Email
minaakbari316@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information.
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
Loading...