ANZCTR - Registration

The ANZCTR website is back online for trial registration and updates. We apologise for any inconvenience caused while the site was inactive.

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

ACTRN12624001413516

Ethics application status

Approved

Date submitted

2/10/2024

Date registered

29/11/2024

Date last updated

29/11/2024

Date data sharing statement initially provided

29/11/2024

Type of registration

Prospectively registered

Titles & IDs

Public title

Effect of exercise on salivary pH and plaque streptococcus mutans count among sports persons in Manipal University College Malaysia (MUCM)

Scientific title

Effect of exercise on salivary pH and plaque streptococcus mutans count among sports persons in Manipal University College Malaysia (MUCM): a cross- over trial

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Streptococcus mutans count in saliva

Condition category

Condition code

Physical Medicine / Rehabilitation

Other physical medicine / rehabilitation

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Participants will do a 20 minutes walk/ run on treadmill at heart rate 50-69% of max Heart rate (HR). Maximum heart is calculated using the formula- (220-age ). Participants will be exercising only once and will be be supervised by researchers and basic life support trainer.
Duration of wash-out period is 7 days.

Intervention code [1]

Lifestyle

Comparator / control treatment

20 minutes seated story telling. Participants will be seated around a round table, and each participant will be asked to share a short random story of their choice. After 20 minutes of story telling, their saliva will be collected and analyzed.

Control group

Active

Outcomes

Primary outcome [1]

Streptococcus mutans count in saliva

Timepoint [1]

stimulated saliva will be collected after 20 minutes exercise/ story telling session

Primary outcome [2]

Salivary buffer capacity

Timepoint [2]

stimulated saliva will be collected after 20 minutes exercise/ story telling session

Secondary outcome [1]

Salivary pH

Timepoint [1]

stimulated saliva will be collected after 20 minutes exercise/ story telling session

Eligibility

Key inclusion criteria

1. "Physically active" - Participation in at least moderate-intensity physical activity for greater than or equal to 30 minutes on most days (4 or more days in a week)
2. Clear Physical Activity Readiness Questionnaire (PAR-Q screening)

Minimum age

18 Years

Maximum age

40 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

1. Use of over-the-counter recreational drugs or performance enhancing supplements
2. Students currently undergoing orthodontics treatment.
3. Students under antibiotic medications in the last 2 weeks
4. Any illness in the past 2 weeks

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation will not be concealed

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

By computerized sequence generation

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

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

Not yet recruiting

Date of first participant enrolment

Anticipated

13/12/2024

Actual

Date of last participant enrolment

Anticipated

13/12/2024

Actual

Date of last data collection

Anticipated

30/03/2025

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Melaka

Funding & Sponsors

Funding source category [1]

University

Name [1]

Manipal University College Malaysia

Address [1]

Country [1]

Malaysia

Primary sponsor type

University

Name

Manipal University College Malaysia

Address

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

MUCM/ Research Ethics Committee

Ethics committee address [1]

Research Ethics Committee, Academic Building, Ground Floor, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

14/06/2023

Approval date [1]

02/11/2023

Ethics approval number [1]

Summary

Brief summary

With physical activity in which a heart rate in increased there are changes expected to occur in the salivary flow, composition and well as oral microflora. Athletes have been documented as having higher caries incidence. However, the effect of physical activity on oral microflora is not well documented. In this study we aim to assess, whether there will be any difference in the number of Streptococcus mutans with or without exercise.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Prof Arunima Chauhan

Address

Faculty of Dentistry, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150

Country

Malaysia

Phone

+6062896662

Fax

[email protected]

Contact person for public queries

Name

Arunima Chauhan

Address

Faculty of Dentistry, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150

Country

Malaysia

Phone

+6062896662

Fax

[email protected]

Contact person for scientific queries

Name

Arunima Chauhan

Address

Faculty of Dentistry, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150

Country

Malaysia

Phone

+6062896662

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

No
No IPD sharing reason/comment: Misuse or misinterpretation

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
24238	Ethical approval					Ethical Approval Certificate (RP056_2023).pdf

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically