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General information
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51
51
No
No
empty
2020-06-07, 1399/03/18
2020-06-07 00:00:00
empty
2020-06-24, 1399/04/04
2020-06-24 00:00:00
empty
2020-06-24, 1399/04/04
2020-06-24 00:00:00
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record actual recruitment start and end date and record trial completion date
record actual recruitment start and end date and record trial completion date
empty
ثبت تاریخ شروع و پایان بیمارگیری تحقق یافته و خاتمه کارآزمایی
ثبت تاریخ شروع و پایان بیمارگیری تحقق یافته و خاتمه کارآزمایی
Recruitment centers
#1
Name of recruitment center - English: Tabriz dentistry faculty
Name of recruitment center - Persian: دانشکده دندانپزشکی تبریز
Full name of responsible person - English: Azin Sohrabi
Full name of responsible person - Persian: آذین سهرابی
Street address - English: Golgasht Ave., Dentistry faculty, Pediatric ward
Street address - Persian: خیابان گلگشت، دانشکده دندانپزشکی، بخش کودکان
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 41 3355 9659
Fax:
Email: azin.sohrabi@gmail.com
Web page address:
Name of recruitment center - English: Tabriz dental faculty
Name of recruitment center - Persian: دانشکده دندانپزشکی تبریز
Full name of responsible person - English: Azin Sohrabi
Full name of responsible person - Persian: آذین سهرابی
Street address - English: Pediatric dentistry department, Dental Faculty, Golgasht Ave.
Street address - Persian: خیابان گلگشت، دانشکده دندانپزشکی، بخش کودکان
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 41 3355 9659
Fax:
Email: azin.sohrabi@gmail.com
Web page address:
Name of recruitment center - English: Tabriz dentistrydental faculty Name of recruitment center - Persian: دانشکده دندانپزشکی تبریز Full name of responsible person - English: Azin Sohrabi Full name of responsible person - Persian: آذین سهرابی Street address - English: Pediatric dentistry department, Dental Faculty, Golgasht Ave., Dentistry faculty, Pediatric ward Street address - Persian: خیابان گلگشت، دانشکده دندانپزشکی، بخش کودکان City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: - Phone: +98 41 3355 9659 Fax: Email: azin.sohrabi@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Assistance of Research and Technology of Tabriz School of Dentistry
Name of organization / entity - Persian: معاونت پژوهش و فناوری دانشکده دندانپزشکی تبریز
Full name of responsible person - English: Mozhgan Kachuei
Full name of responsible person - Persian: مژگان کچوئی
Street address - English: Golgasht Ave., Dentistry Faculty
Street address - Persian: خیابان گلگشت، دانشکده دندانپزشکی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 41 3334 0310
Fax:
Email: kachoei@tbzmed.ac.ir
Web page address:
contact.organization_id:
Name of organization / entity - English: Assistance of Research and Technology of Tabriz School of Dentistry
Name of organization / entity - Persian: معاونت پژوهش و فناوری دانشکده دندانپزشکی تبریز
Full name of responsible person - English: Mozhgan Kachuei
Full name of responsible person - Persian: مژگان کچوئی
Street address - English: Dental Faculty, Golgasht Ave.
Street address - Persian: خیابان گلگشت، دانشکده دندانپزشکی
City - English: Tabriz
City - Persian: تبریز
Province: East Azarbaijan
Country: Iran (Islamic Republic of)
Postal code: -
Phone: +98 41 3334 0310
Fax:
Email: kachoei@tbzmed.ac.ir
Web page address:
contact.organization_id: Name of organization / entity - English: Assistance of Research and Technology of Tabriz School of Dentistry Name of organization / entity - Persian: معاونت پژوهش و فناوری دانشکده دندانپزشکی تبریز Full name of responsible person - English: Mozhgan Kachuei Full name of responsible person - Persian: مژگان کچوئی Street address - English: Dental Faculty, Golgasht Ave., Dentistry Faculty Street address - Persian: خیابان گلگشت، دانشکده دندانپزشکی City - English: Tabriz City - Persian: تبریز Province: East Azarbaijan Country: Iran (Islamic Republic of) Postal code: - Phone: +98 41 3334 0310 Fax: Email: kachoei@tbzmed.ac.ir Web page address:
Protocol summary
Study aim
Comparison of salivary pH changes in children aged 6 to 12 following the use of fruit , plain and probiotic yogurt
Design
clinical trial, Randomised, Single blinded, Sample size: 51, Number of people in each group: 17
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
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.
Main outcome variables
salivary pH
General information
Reason for update
record actual recruitment start and end date and record trial completion date
Acronym
IRCT registration information
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
Registration date
2020-04-22, 1399/02/03
Registrant information
Name
Azin Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3332 2938
Email address
azin.sohrabi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-07-15, 1399/04/25
Actual recruitment start date
2020-06-07, 1399/03/18
Actual recruitment end date
2020-06-24, 1399/04/04
Trial completion date
2020-06-24, 1399/04/04
Scientific title
Comparison of salivary pH changes in children aged 6 to 12 following the use of fruit , plain and probiotic yogurt
Public title
Comparison of salivary pH changes in children aged 6 to 12 following the use of fruit , plain and probiotic yogurt
Purpose
Prevention
Inclusion/Exclusion criteria
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
Age
From 6 years old to 12 years old
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
51
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
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)
Blinding (investigator's opinion)
Single blinded
Blinding description
The analyzer does not know the type of consumable and the consumable is marked with the codes A,B,C.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Golgasht Ave.
City
Tabriz
Province
East Azarbaijan
Postal code
-
Approval date
2020-02-17, 1398/11/28
Ethics committee reference number
IR.TBZMED.REC.1398.1254
Health conditions studied
1
Description of health condition studied
Dental caries
ICD-10 code
K02
ICD-10 code description
Dental caries
Primary outcomes
1
Description
Salivary pH
Timepoint
Before the intervention and 10 minutes after the intervention
Method of measurement
pH meter
Secondary outcomes
empty
Intervention groups
1
Description
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.
Category
Prevention
2
Description
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.
Category
Prevention
3
Description
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.