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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] 313096 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Streptococcus mutans count in saliva 335339 0
Condition category
Condition code
Physical Medicine / Rehabilitation 331928 331928 0 0
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] 329654 0
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] 339526 0
Streptococcus mutans count in saliva
Timepoint [1] 339526 0
stimulated saliva will be collected after 20 minutes exercise/ story telling session
Primary outcome [2] 339527 0
Salivary buffer capacity
Timepoint [2] 339527 0
stimulated saliva will be collected after 20 minutes exercise/ story telling session
Secondary outcome [1] 440345 0
Salivary pH
Timepoint [1] 440345 0
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
75
Accrual to date
Final
Recruitment outside Australia
Country [1] 26599 0
Malaysia
State/province [1] 26599 0
Melaka

Funding & Sponsors
Funding source category [1] 317540 0
University
Name [1] 317540 0
Manipal University College Malaysia
Country [1] 317540 0
Malaysia
Primary sponsor type
University
Name
Manipal University College Malaysia
Address
Country
Malaysia
Secondary sponsor category [1] 319847 0
None
Name [1] 319847 0
Address [1] 319847 0
Country [1] 319847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316253 0
MUCM/ Research Ethics Committee
Ethics committee address [1] 316253 0
Ethics committee country [1] 316253 0
Malaysia
Date submitted for ethics approval [1] 316253 0
14/06/2023
Approval date [1] 316253 0
02/11/2023
Ethics approval number [1] 316253 0

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

Contacts
Principal investigator
Name 137294 0
Prof Arunima Chauhan
Address 137294 0
Faculty of Dentistry, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150
Country 137294 0
Malaysia
Phone 137294 0
+6062896662
Fax 137294 0
Email 137294 0
chauhan.arunima@gmail.com
Contact person for public queries
Name 137295 0
Arunima Chauhan
Address 137295 0
Faculty of Dentistry, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150
Country 137295 0
Malaysia
Phone 137295 0
+6062896662
Fax 137295 0
Email 137295 0
chauhan.arunima@gmail.com
Contact person for scientific queries
Name 137296 0
Arunima Chauhan
Address 137296 0
Faculty of Dentistry, Manipal University College Malaysia, Bukit Baru, Melaka, Malaysia, 75150
Country 137296 0
Malaysia
Phone 137296 0
+6062896662
Fax 137296 0
Email 137296 0
chauhan.arunima@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Misuse or misinterpretation


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
24238Ethical approval    388559-(Uploaded-02-10-2024-18-06-00)-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.