ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

dental caries

Condition category

Condition code

Oral and Gastrointestinal

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]

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]

The salivary pH of resting saliva will be measured using Macherey-Nagel pH Indicator Strips.

Timepoint [1]

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]

Nil

Timepoint [1]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

Syrian Arab Republic

State/province [1]

Funding & Sponsors

Funding source category [1]

University

Name [1]

Damascus University

Address [1]

Damascus University, Mazzeh Highway, Damascus, Syria

Country [1]

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]

Individual

Name [1]

Nada Bshara

Address [1]

Nada Bshara, Damascus University, Mazzeh Highway, Damascus, Syria

Country [1]

Syrian Arab Republic

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Damascus University

Ethics committee address [1]

Mazzeh Highway, Damascus University, Damascus, Syria

Ethics committee country [1]

Syrian Arab Republic

Date submitted for ethics approval [1]

01/05/2023

Approval date [1]

09/05/2023

Ethics approval number [1]

Summary

Brief summary

Nutrition is essential for the growth and development. A healthy diet must meet the body's energy, caloric requirements and provide essential nutrients to meet physiological needs, especially in children. Milk is the first food for humans and the only food found in nature that is richer in nutrients which the body needs, as it provides many of nutrients that are necessary for human body growth in proportionate amounts.
Drinking sweetened and flavored processed  milk is part of the children's diet It is known that milk is a non-cariogenic food , this study aimed to monitor saliva pH changes after consuming three different types of canned sweetened milk in children with different incidence of dental caries at the age of 3 -5 years.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Mawia Karkoutly

Address

Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria

Country

Syrian Arab Republic

Phone

+963992647528

Fax

[email protected]

Contact person for public queries

Name

Mawia Karkoutly

Address

Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria

Country

Syrian Arab Republic

Phone

+963992647528

Fax

[email protected]

Contact person for scientific queries

Name

Mawia Karkoutly

Address

Mawia Karkoutly, Damascus University, Mazzeh Highway, Damascus, Syria

Country

Syrian Arab Republic

Phone

+963992647528

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

Demographic data

When will data be available (start and end dates)?

After the requesting date and available for 5 years after publication

Available to whom?

Reviewers/Editors

Available for what types of analyses?

Descriptive

How or where can data be obtained?

via website (https://zenodo.org/)

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

Source	Title	Year of Publication	DOI
Dimensions AI	Effect of various types of milk on salivary pH among children: a pilot randomized controlled crossover trial	2023	https://doi.org/10.1038/s41405-023-00170-8

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Documents added manually

Documents added automatically