Comparison of Salivary pH After Consuming Milk of Origin Vegetable vs Cow's Milk in Children

January 15, 2021 updated by: Annia Marisol Avalos Mejía, Universidad Tecnologica de Mexico
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female. They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk)

Study Overview

Detailed Description

  • The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
  • The group was given a brushing technique using a model and 2 videos were shown to reinforce the brushing technique and explanation of what was going to be done in the study.
  • Supervised tooth brushing was performed in a group of 5 people.
  • They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
  • Each child was given 7 plastic cups each day and asked to pour their saliva into the cup when instructed.
  • The samples were taken with pH indicator strips and the result was recorded in personalized tables.

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Mexico City, Mexico, 11320
        • UNITEC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 6 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Boys and girls from 3 to 6 years

Exclusion Criteria

  • Boys and girls with allergies
  • Children with lactose intolerance

Elimination criteria:

- Boys and girls who do not want to participate at the time of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: pH milk
Group of children who were given the different types of milk and only the pH was measured
They were given 5 types of milk, each one was measured on different days (Monday cow's milk, Tuesday coconut milk, Wednesday almond milk, Thursday soy milk, Friday rice milk).
Other Names:
  • cow´s milk, coconut milk, almond milk, soy milk and rice milk

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic results
Time Frame: 1 hour the sociodemographic data of all the children were taken.
The study was carried out in 21 first grade primary school children, 100% aged 6 years, 52.4% were female.
1 hour the sociodemographic data of all the children were taken.
pH results
Time Frame: The average time of pH evaluation for each milk per child was an hour and a half.

30 minutes after tooth brushing, each child was asked for the first saliva sample (basal pH measurement).

After taking the basal pH, each child was given a glass with 50 ml of the milk to be measured.

Saliva samples were measured with pH indicator strips and the result was recorded on custom charts.

The pH was taken at 5, 10, 20, 30, 40 and 50 minutes.

The normality distribution test (Shapiro-Wilk) was applied to the quantitative variables, with p = 0.0001, so that the data present a non-parametric or free distribution.

To assess whether there were differences between the pH of the groups, the Kuskal-Wallis test was applied. For basal pH, p = 0.0001, therefore the null hypothesis is rejected and we conclude that the basal pH level is different in the five milks. Average basal pH:

Rice milk 7 Cow milk 6.9 Almond milk 6.6 Soy milk 6.4 Coconut milk 6

The average time of pH evaluation for each milk per child was an hour and a half.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Annia Avalos, Master, Universidad Tecnológica Centroamericana

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 13, 2020

Primary Completion (ACTUAL)

January 17, 2020

Study Completion (ACTUAL)

January 17, 2020

Study Registration Dates

First Submitted

January 12, 2021

First Submitted That Met QC Criteria

January 15, 2021

First Posted (ACTUAL)

January 22, 2021

Study Record Updates

Last Update Posted (ACTUAL)

January 22, 2021

Last Update Submitted That Met QC Criteria

January 15, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Other Study ID Numbers

  • 2019-100

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We are working on the article to publish it and for the study to be available.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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