Trial Review

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With activity expected to increase on the ANZCTR again, there may be extended wait times while we process pending studies, with priority being given to those trials submitted in February. Thank you for your patience.


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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12623000773639
Ethics application status
Approved
Date submitted
22/05/2023
Date registered
17/07/2023
Date last updated
17/07/2023
Date data sharing statement initially provided
17/07/2023
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of various types of milk on salivary pH among children
Scientific title
Effect of various types of milk on salivary pH among children: a randomized controlled crossover trial
Secondary ID [1] 309704 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
dental caries 330084 0
Condition category
Condition code
Oral and Gastrointestinal 326980 326980 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Children have undergone in three experimental sessions with a one-week washout period. The salivary pH of resting saliva will be measured before (control), then the dietician gave the participants 355 mL of one of the following types of milk: 1. high-protein milk, 2. full-fat milk, and 3. sweetened milk. The salivary pH will be measured after 5, 10, 15, 30, and 60 minutes.
High protein milk is made up of 100% skimmed cow's milk, it contains 8.3g of protein per 100 ml. Full-fat milk contains 3.5% of fat. The participants will be asked to consume the milk within 10 minutes. The investigator ask the participant to return the empty milk containers.
Intervention code [1] 326140 0
Treatment: Other
Comparator / control treatment
This is a crossover randomized controlled trial (with the objective that each individual will be their own comparator).
Control group
Active

Outcomes
Primary outcome [1] 334818 0
The salivary pH of resting saliva will be measured using Macherey-Nagel pH Indicator Strips.
Timepoint [1] 334818 0
The salivary pH of resting saliva will be measured before milk ingestion and then at 5, 10, 15, 30 and 60 minutes post-milk ingestion for each type of milk assessed.
Secondary outcome [1] 422180 0
Nil
Timepoint [1] 422180 0
Nil

Eligibility
Key inclusion criteria
Healthy children
Cooperative children
Minimum age
3 Years
Maximum age
5 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Taking medications that reduce salivary flow rate.
intolerance to milk protein.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
4/01/2023
Date of last participant enrolment
Anticipated
Actual
11/01/2023
Date of last data collection
Anticipated
Actual
5/02/2023
Sample size
Target
30
Accrual to date
Final
30
Recruitment outside Australia
Country [1] 25550 0
Syrian Arab Republic
State/province [1] 25550 0

Funding & Sponsors
Funding source category [1] 313897 0
University
Name [1] 313897 0
Damascus University
Country [1] 313897 0
Syrian Arab Republic
Primary sponsor type
Individual
Name
Mawia Karkoutly
Address
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country
Syrian Arab Republic
Secondary sponsor category [1] 315750 0
Individual
Name [1] 315750 0
Nada Bshara
Address [1] 315750 0
Nada Bshara, Damascus University, Mazzeh Highway, Damascus, Syria
Country [1] 315750 0
Syrian Arab Republic

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313044 0
Damascus University
Ethics committee address [1] 313044 0
Ethics committee country [1] 313044 0
Syrian Arab Republic
Date submitted for ethics approval [1] 313044 0
01/05/2023
Approval date [1] 313044 0
09/05/2023
Ethics approval number [1] 313044 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126794 0
Dr Mawia Karkoutly
Address 126794 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 126794 0
Syrian Arab Republic
Phone 126794 0
+963992647528
Fax 126794 0
Email 126794 0
[email protected]
Contact person for public queries
Name 126795 0
Mawia Karkoutly
Address 126795 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 126795 0
Syrian Arab Republic
Phone 126795 0
+963992647528
Fax 126795 0
Email 126795 0
[email protected]
Contact person for scientific queries
Name 126796 0
Mawia Karkoutly
Address 126796 0
Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria
Country 126796 0
Syrian Arab Republic
Phone 126796 0
+963992647528
Fax 126796 0
Email 126796 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Reviewers/Editors

Conditions for requesting access:
• -

What individual participant data might be shared?
• Demographic data

What types of analyses could be done with individual participant data?
• Descriptive

When can requests for individual participant data be made (start and end dates)?
From:
After the requesting date and available for 5 years after publication

To:
-

Where can requests to access individual participant data be made, or data be obtained directly?
• via website (https://zenodo.org/)

Are there extra considerations when requesting access to individual participant data?
No


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
Dimensions AIEffect of various types of milk on salivary pH among children: a pilot randomized controlled crossover trial2023https://doi.org/10.1038/s41405-023-00170-8
N.B. These documents automatically identified may not have been verified by the study sponsor.