Evaluation of changes of dental plaque as well as caries in maxillary incisors after using of Silver Diamine Fluoride and coconut oil among children with Early Childhood Caries
Changes of dental plaque and caries after using of Silver Diamine Fluoride and coconut oil among children with Early Childhood Caries
Design
60 children under 6 years of age are randomly selected and divided into 3 groups with a table of random numbers. The study is single blinded, and patients do not know what substance they're using.
Settings and conduct
Patients do not know what substance is used for them. The place of study is in Kerman Dental School. On the first and thirtieth day of the study, plaque samples and photographs are taken from patients.
Participants/Inclusion and exclusion criteria
Complete physical health, Proper cooperation of the child and parents, Do not take antibiotics, Do not use mouthwash or fluoride gel or xylitol chewing gum for 1 month before the start of the study, Absence of deep caries in the anterior maxillary teeth with the possibility of pulpal involvement, No allergies to metals, especially silver and coconut oil and products with coconut essential oil
Intervention groups
The first group is as a control and no substance is used for them
The second group uses the 30% SDF (Biodinamica) on the first and fifteenth day of the study by insulating it with a cotton roll and cleaning the teeth with gauze and a drop of the substance is applied to the teeth. Then wait 1-3 minutes.
For the third group, coconut oil is used once a day for four weeks. The area is isolated with a cotton roll, then the teeth are cleaned with sterile gauze and then some coconut oil is applied on the teeth.
Main outcome variables
Bacterial changes of dental plaque
Changes in the clinical appearance of teeth
General information
Reason for update
Acronym
"ECC" "SDF"
IRCT registration information
IRCT registration number:IRCT20201202049571N1
Registration date:2020-12-12, 1399/09/22
Registration timing:prospective
Last update:2020-12-12, 1399/09/22
Update count:0
Registration date
2020-12-12, 1399/09/22
Registrant information
Name
Marzieh Pirzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9021
Email address
far.pirzadeh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-01-09, 1399/10/20
Expected recruitment end date
2021-02-08, 1399/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of changes of dental plaque as well as caries in maxillary incisors after using of Silver Diamine Fluoride and coconut oil among children with Early Childhood Caries
Public title
Changes of caries after using of Silver Diamine Fluoride and coconut oil
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Complete physical health
Proper cooperation of the child and parents
Exclusion criteria:
Do not take antibiotics
Do not use mouthwash or fluoride gel or xylitol chewing gum for 1 month before the start of the study
Absence of deep caries in the anterior maxillary teeth with the possibility of pulpal involvement
No allergies to metals, especially silver and coconut oil and products with coconut essential oil
Age
From 2 years old to 6 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Simple random sample,
Individual, Random number tables
Blinding (investigator's opinion)
Single blinded
Blinding description
Each person has a specific number that is divided into 3 groups based on a table of random numbers. Participants have no information about the use of the material and the material is removed from the same container and consumed in the same way and the presence time of the groups does not interfere.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kerman University of Medical Sciences
Street address
Jahad blvd - Ebnesina avenue
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2020-11-30, 1399/09/10
Ethics committee reference number
IR.KMU.REC.1399.479
Health conditions studied
1
Description of health condition studied
Decay
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Changes in dental plaque bacteria
Timepoint
The first and thirtieth day
Method of measurement
Catalase test and fermentation of mannitol and sorbitol
2
Description
Appearance changes
Timepoint
The first and thirtieth day
Method of measurement
ICDAS code
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The second group on the first and fifteenth day, 30% SDF (Biodinamica) is used in isolation with a cotton roll and to prevent the lips and saliva from hitting the teeth. The teeth are cleaned with gauze and then a drop of the substance is applied to the teeth by the applicator. The excess liquid is removed from the tooth surface with gauze or cotton and then wait for 1-3 minutes.
Category
Prevention
2
Description
Intervention group 2: Coconut oil is used once a day for four weeks. The area is isolated with a cotton roll, then the teeth are cleaned with sterile gauze and then some coconut oil is applied on the teeth with an applicator so that the teeth are completely oiled.
Category
Prevention
3
Description
Control group: No substance is used for them
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Kerman Dental School
Full name of responsible person
Marzieh Pirzadeh
Street address
Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Fax
+98 34 3211 8073
Email
far.pirzadeh@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Abbas Pardakhty
Street address
Shafa street
City
kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
far.pirzadeh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman 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
Kerman University of Medical Sciences
Full name of responsible person
Marzieh Pirzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shafa Street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
far.pirzadeh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Marzieh Pirzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
far.pirzadeh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Marzieh Pirzadeh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dentistry
Street address
Shafa street
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 9021
Email
far.pirzadeh@gmail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available