Protocol summary
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Study aim
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Comparison of salivary pH changes in children aged 6 to 12 following the use of fruit , plain and probiotic yogurt
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Design
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clinical trial, Randomised, Single blinded, Sample size: 51, Number of people in each group: 17
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Settings and conduct
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Participants will be randomly divided into 3 groups of 17(A,B,C). In the day of experiment, an unstimulated saliva sample will be taken from each participant one hour after breakfast and then 10cc of selected yogurt is given to each participant and after 10 minutes another saliva sample is taken. The pH of both samples is calculated for participant by a pH meter, and the difference in these two values is considered as the pH change. The result will be reported (percent), mean ± SD-bearing for quantitative and qualitative variable. To compare the pH in and between the studied groups, the pair t-test and the analysis of Covariance(ANCOVA) will be used. To analyze the data, SPSS 17 will be used. The probability of less than 0.05 as a significant level will be considered.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
1.Obtaining parental consent to participate in the study
2.In the age group of 6-12 years
3.With good cooperation
4.Without systemic disease
5.No consumption any medicine
6.No orthodontic or prosthetic appliance in mouth
7.Symptom free such as toothache, etc
Exclusion criteria:
1.Diagnosed with dry mouth
2.Allergy to yogurt or milk protein
3.With pathological lesions
4.With previous history of antibiotic therapy from 2 weeks ago
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Intervention groups
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1. One hour after breakfast, intervention with consumption of 10 cc fruit yogurt (peach) will be done.
2. One hour after breakfast, intervention with consumption of 10 cc plain yogurt will be done.(control group)
3. One hour after breakfast, intervention with consumption of 10 cc probiotic yogurt will be done.
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Main outcome variables
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salivary pH
General information
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Reason for update
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record actual recruitment start and end date and record trial completion date
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200411047018N1
Registration date:
2020-04-22, 1399/02/03
Registration timing:
prospective
Last update:
2020-07-04, 1399/04/14
Update count:
1
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Registration date
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2020-04-22, 1399/02/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-06-21, 1399/04/01
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Expected recruitment end date
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2020-07-15, 1399/04/25
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Actual recruitment start date
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2020-06-07, 1399/03/18
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Actual recruitment end date
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2020-06-24, 1399/04/04
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Trial completion date
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2020-06-24, 1399/04/04
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Scientific title
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Comparison of salivary pH changes in children aged 6 to 12 following the use of fruit , plain and probiotic yogurt
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Public title
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Comparison of salivary pH changes in children aged 6 to 12 following the use of fruit , plain and probiotic yogurt
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Purpose
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Prevention
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Inclusion/Exclusion criteria
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Inclusion criteria:
Obtaining parental consent to participate in the study
In the age group of 6-12 years
With good cooperation
Without systemic disease
No consumption any medicine
No orthodontic or prosthetic appliance in mouth
Symptom free such as toothache, etc
Exclusion criteria:
Diagnosed with dry mouth
Allergy to yogurt or milk protein
With pathological lesions
With previous history of antibiotic therapy from 2 weeks ago
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Age
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From 6 years old to 12 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
51
Actual sample size reached:
51
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization, individual, roll of a die (number 1,2 for group A, number 3,4 for group B, number 5,6 for group C)
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The analyzer does not know the type of consumable and the consumable is marked with the codes A,B,C.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-17, 1398/11/28
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Ethics committee reference number
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IR.TBZMED.REC.1398.1254
Health conditions studied
1
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Description of health condition studied
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Dental caries
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ICD-10 code
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K02
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ICD-10 code description
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Dental caries
Primary outcomes
1
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Description
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Salivary pH
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Timepoint
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Before the intervention and 10 minutes after the intervention
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Method of measurement
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pH meter
Intervention groups
1
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Description
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Intervention group: One hour after breakfast, each person is given 10 cc of fruit yogurt (peach, all three of which are the products of a yogurt company) and should be kept in the mouth for 2 minutes.
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Category
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Prevention
2
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Description
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Control group: One hour after breakfast, each person is given 10 cc of plain yogurt (all three of which are the products of a yogurt company) and should be kept in the mouth for 2 minutes.
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Category
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Prevention
3
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Description
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Intervention group: One hour after breakfast, each person is given 10 cc of probiotic yogurt (all three of which are the products of a yogurt company) and should be kept in the mouth for 2 minutes.
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Category
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Prevention
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Assistance of Research and Technology of Tabriz School of Dentistry
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available