Determining the Salivary pH and Calcium Levels After Eating Cheese and Curd in Children Aged 4-6 Years.
Design
Clinical trial. With two parallel groups of 15 people, double-blind, randomized. Phase 3 on 30 patients. The coin toss method will be used for randomization.
Settings and conduct
In the pediatric department of the Faculty of Dentistry, first one of the dairy compounds (cheese or curd) is given to children, and the saliva sample is collected in three stages and sent to the laboratory to measure the pH and calcium level of the saliva. The The laboratory technician and Statistics specialist are blinded
Participants/Inclusion and exclusion criteria
Children Aged 4 to 6 Years Who Are Systemically Healthy are Included in the Study.
Children Who Use Orthodontic Appliances, or are Allergic to Dairy Ingredients, or Who do not Cooperate Properly to Conduct the Study, Will not be Included.
Intervention groups
Intervention groups1 and 2: In the children of the first and second group (15 people in every group), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the first and second group are given 50 grams of curd and 50 grams of chees to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva.
Main outcome variables
Determining changes in pH and calcium level of saliva
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171020036896N10
Registration date:2023-09-26, 1402/07/04
Registration timing:prospective
Last update:2023-09-26, 1402/07/04
Update count:0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 32119023
Email address
sajadi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-12, 1402/07/20
Expected recruitment end date
2024-01-10, 1402/10/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessment the Effect of Cheese and Curd Consumption on Salivary pH and Calcium in Preschool Children
Public title
Assessment the Effect of Cheese and Curd on Salivary pH and Calcium
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children with 4 to 6 Years-Old
Absence of Systemic Disease
Appropriate Cooperation to Conduct the Study
Exclusion criteria:
Using Orthodontic Appliances
Taking Antibiotics within Two Weeks Before the Start of the Study
Having Extensive Restorations and Permanent or Temporary Restorations Containing Glass Ionomer
Having an Allergy to Dairy Ingredients
Age
From 4 years old to 6 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
In this Study, the Simple Randomization Method (Flip the Coin) will be Used.In Such a Way that One of the Study Groups will be Considered as Heads and the Other Group will be Considered as Tails. Then the Same Number of Coins will be Thrown Based on the Sample Size. Finally, to Prevent Disclosure of Random Sequencing, the Allocation Concealment will be Used.
Blinding (investigator's opinion)
Double blinded
Blinding description
The Biochemist in the Laboratory does not Know the Type of Compound Used in Children. The Statistics Consultant is also not Aware of the Type of Combination Used.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethical committee of Kerman University of Medical Sciences
Street address
Ebn Sina Avenue , Jahad Blvd ,
City
Kerman
Province
Kerman
Postal code
7618759689
Approval date
2022-11-07, 1401/08/16
Ethics committee reference number
IR.KMU.REC.1401.370
Health conditions studied
1
Description of health condition studied
Salivary pH and Calcium
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Salivary pH
Timepoint
Before, Immediately after and Half an Hour after Eating the Dairy Composition
Method of measurement
pH of saliva is Measured by pH Meter
2
Description
Salivary Calcium
Timepoint
Before, Immediately after and Half an Hour after Eating the Dairy Composition
Method of measurement
Calcium Concentration of Saliva is Measured by Colorimetric Method
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group1: In the children of the first group (15 people), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the first group are given 50 grams of curd to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva.
Category
Prevention
2
Description
Intervention group 2: In the children of the second group (15 people), complete oral prophylaxis with a rubber cap will be done in the clinic and the mouth will be washed with plain water. Then, non-stimulating children's saliva samples are collected. In this way, children are asked to empty their saliva into disposable plastic coded containers with lids. The collected samples are taken to the laboratory to measure the pH and calcium of the saliva. Then all the children in the second group are given 50 grams of chees to chew and roll it for three minutes and then swallow it. After that, the mouth will be washed with plain water and a non-stimulating saliva sample (5 cc) will be collected immediately after consumption and 30 minutes later, and will be sent to the laboratory to measure the calcium concentration and pH of the saliva.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Faculty of Dentistry
Full name of responsible person
Fatemeh Sadat Sajadi
Street address
Shafa Ave
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fsajadi1234@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Dr.Abedin Iranpour
Street address
Shafa Ave.,
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fsajadi1234@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
Fatemeh Sadat Sajadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave.,
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fsajadi1234@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave.,
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fsajadi1234@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Kerman University of Medical Sciences
Full name of responsible person
Fatemeh Sadat Sajadi
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shafa Ave.,
City
Kerman
Province
Kerman
Postal code
7618759689
Phone
+98 34 3211 8074
Email
fsajadi1234@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