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Comparison of salivary pH in students after consuming Lakido, Milk, shirakacao, carbonated beverages.

Protocol summary

Study aim
Comparison of saliva pH in students after consuming Lacido drink, milk, cocoa milk, carbonated beverage
Design
Randomized controlled trial with control group, with parallel group; One blind, random
Settings and conduct
This study was performed in Birjand Dental School of South Khorasan Province in 1400. 80 students are randomly divided into 5 groups receiving Acido, milk, cocoa milk, carbonated beverage and water (control). At the beginning of the study, participants were collected before and immediately after drinking, 5, 20, 40 and 60 minutes after drinking. The pH will be measured by a laboratory expert.
Participants/Inclusion and exclusion criteria
Inclusion criteria include: having informed consent to participate in the study, having complete physical health, not taking antibiotics from two weeks before going to the dentist, not having a special diet, not having dry mouth, not using orthodontic plaque or prosthesis, Absence of periodontal disease and active caries and exclusion criteria: Lack of proper cooperation when drinking beverages and measuring salivary pH.
Intervention groups
Students of Birjand University of Medical Sciences with inclusion and exclusion criteria will be randomly assigned to one of the groups consuming Lacido drink, milk, cocoa milk, carbonated beverage of 80 cc.
Main outcome variables
PH saliva

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190618043934N8
Registration date: 2021-04-14, 1400/01/25
Registration timing: prospective

Last update: 2021-04-14, 1400/01/25
Update count: 0
Registration date
2021-04-14, 1400/01/25
Registrant information
Name
Zabihullah Mohaghegh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 56 3232 3232
Email address
oabstudent@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-20, 1400/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of salivary pH in students after consuming Lakido, Milk, shirakacao, carbonated beverages.
Public title
Effect of some types of drinks on saliva pH
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having informed consent to participate in the study having complete physical health not taking antibiotics from two weeks before going to the dentist not having a special diet not having dry mouth not using orthodontic plaque or prosthesis lack of periodontal disease lack of caries active.
Exclusion criteria:
Lack of proper cooperation when drinking beverages Insufficient saliva to measure pH
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 16
More than 1 sample in each individual
Number of samples in each individual: 6
Saliva samples were collected in pre-drink, immediately after drinking, 5, 20, 40 and 60 minutes after drinking in a test tube.
Randomization (investigator's opinion)
Randomized
Randomization description
Lottery method of Simple random sampling
Blinding (investigator's opinion)
Single blinded
Blinding description
Outcome Assessor: The comprehensive research laboratory expert assesses and reports the pH of saliva without knowing the type of drink consumed by the participant. The data analyzer will also analyze the data without knowing the location of the individuals in each group.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Birjand University of Medical
Street address
Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717811674
Approval date
2020-09-28, 1399/07/07
Ethics committee reference number
IR.BUMS.REC.1399.298

Health conditions studied

1

Description of health condition studied
Decay
ICD-10 code
K02
ICD-10 code description
Dental caries

Primary outcomes

1

Description
PH Saliva
Timepoint
Before and immediately after drinking, 0, 5, 20, 40 and 60 after drinking each drink
Method of measurement
Using the pH meter in the comprehensive research laboratory of Birjand University of Medical Sciences will be evaluated by an expert.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Students receiving Lakido drink (Kaleh-Iran Company) in the amount of 80 cc.
Category
Prevention

2

Description
Intervention group: Students receiving milk drink (Pegah Company - Iran) in the amount of 80 cc.
Category
Prevention

3

Description
Intervention group: Students receiving cocoa milk drink (Pegah Company - Iran) in the amount of 80 cc.
Category
Prevention

4

Description
Intervention group: Students receiving carbonated soft drinks (Coca-Cola Company - Iran) in the amount of 80 cc.
Category
Prevention

5

Description
Control group: Students receiving mineral water drinks (Desani Company - Iran) in the amount of 80 cc.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Birjand University of Medical Sciences
Full name of responsible person
Farzad Mogharabi
Street address
Avini Blvd
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
public_r@bums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Zabihuulah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr. Mehrnaz Khademi
Position
Member of the Faculty
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pasdaran Blvd
City
Birjand
Province
South Khorasan
Postal code
9717853577
Phone
+98 56 3239 5000
Email
oabstudent@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Zabihullah Mohaghegh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
General Practitioner
Street address
Ghaffari Blvd
City
Birjand
Province
South Khorasan
Postal code
9717934888
Phone
+98 56 3232 3232
Email
oabstudent@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
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