- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04670341
The Effect of Chewing the Tapioca Pearls in Bubble Tea Drinks
December 15, 2020 updated by: Juni Handajani, Gadjah Mada University
Quality Improvement of Saliva by Chewing Tapioca Pearls in Bubble Tea Drinks
Bubble tea drinks contain tea and tapioca pearls.
Chewing tapioca pearls in bubble tea drinks may increase salivary components.
Because of its proteins, inorganic components, and enzymes, saliva plays an important role in the body's defense against bacteria and viruses.
This study aims to analyze the effect of chewing the tapioca pearls in bubble tea drinks on salivary C-reactive protein (CRP) and calcium (Ca) levels.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Sixty saliva samples were collected from 15 subjects.
The inclusion criterion was 18-25 years of age.
The exclusion criteria were receiving medication, using dentures, a history of dry mouth, smoking and systemic disease.
In the first week of the experiment, subjects drank bubble tea as the intervention group.
In the second week, the same subjects drank tea without pearls as the control group.
Each subject drank the bubble tea for 5 minutes per day over 3 days.
Saliva samples were collected on the first day before bubble tea consumption (pretest) and on the third day after tea consumption (posttest).
Saliva collection was performed in the morning (09:00 a.m.-12:00 p.m.) for 1 minute.
Salivary CRP levels were measured using an ELISA kit, and Ca levels were determined using a test kit.
Study Type
Interventional
Enrollment (Actual)
15
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
-
-
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Yogyakarta, Indonesia, 55281
- Faculty of Dentistry, Universitas Gadjah Mada
-
-
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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- good Oral Hygiene Index-Simplified (OHI-S) score
Exclusion Criteria:
- taking medication
- a history of dry mouth
- smoking
- systemic disease
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: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: chewing tapioca pearls in the bubble tea drinks
In the first week, the subjects drink as much as 100 ml of bubble tea over a span of 5 minutes once a day for 3 days
|
Saliva was collected on the first day before bubble tea consumption (pretest) and on the third day after bubble tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).
|
Placebo Comparator: drink tea without chewing tapioca pearls
In the second week, the subjects drink tea without tapioca pearls as much as 100 ml for 5 minutes per day for 3 days.
|
Saliva was collected on the first day before drink tea without tapioca pearl (pretest) and on the third day after tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Salivary C-reactive protein (CRP) level
Time Frame: 3 days
|
Salivary CRP level was measured on the first day before chewing tapioca peals in the bubble tea drinks and drink tea.
Salivary CRP level was measured on the third day after drink bubble tea and tea without tapioca pearls
|
3 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Calcium (Ca) level
Time Frame: 3 days
|
Ca level was measured on the first day before chewing tapioca peals in the bubble tea drinks and drink tea.
Ca level was measured on the third day after drink bubble tea and tea without tapioca pearls
|
3 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Juni Handajani, PhD, Faculty of Dentistry, Universitas Gadjah Mada
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)
September 17, 2020
Primary Completion (Actual)
October 17, 2020
Study Completion (Actual)
October 17, 2020
Study Registration Dates
First Submitted
December 9, 2020
First Submitted That Met QC Criteria
December 15, 2020
First Posted (Actual)
December 17, 2020
Study Record Updates
Last Update Posted (Actual)
December 17, 2020
Last Update Submitted That Met QC Criteria
December 15, 2020
Last Verified
December 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- FKGUGM1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
Yes
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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