NCT06562699

Brief Summary

This study is conducted to evaluate the buffering capacity of hot matcha brew in comparison with cold matcha brew and water on salivary pH after an acidic attack using a digital pH meter. Research Question: Will matcha green tea beverage have similar salivary buffering effect as water after an acidic challenge on dental interns? Steps in short

  1. 1.Recruitment of the patients and clinical examination with medical and dental history taking.
  2. 2.Informed consent taking for the eligible participants to participate in the study.
  3. 3.A volume of 2 mL saliva samples will be collected before the commencement of acidic attack, baseline (T0).
  4. 4.After the acidic attack, saliva will be collected again by spitting method and their pH value will be measured (T1).
  5. 5.After 5 minutes of the acidic attack, participants will be instructed to swish either hot matcha tea, cold matcha tea, or water then swallow, and saliva samples will be collected (T2).
  6. 6.Then saliva will be collected after 10 (T3), 20 (T4), 30 (T5), and 40 (T6) minutes.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
63

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 11, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 20, 2024

Completed
12 days until next milestone

Study Start

First participant enrolled

September 1, 2024

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

August 20, 2024

Status Verified

August 1, 2024

Enrollment Period

1 month

First QC Date

August 11, 2024

Last Update Submit

August 18, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • Salivary pH buffering effect

    PH will be assessed by a digital pH meter (AD1030, Adwa Instruments, Hungary). Calibration of the pH meter will be performed before measuring. The glass electrode will be immersed in the saliva sample, and after each measurement, it will be carefully cleaned with deionized water and dried with filter paper. The salivary pH value will be determined by 3 consecutive immersions of the pH meter glass electrode in the test tube with the sample, and the mean value will be taken as the obtained value. Measurements will be taken at baseline, 5 mins after the acidic attack, 5, 10, 20, 30, and 40 minutes after consumption of the buffering beverages.

    60 minutes

Study Arms (3)

Group A

EXPERIMENTAL

21 participants. They will be generated using numbers from 1 to 63, divided into three groups denoting with letters A, B, and C. Randomization will be generated using (www.randomization.com).

Other: Hot Matcha brew

Group B

EXPERIMENTAL

21 participants. They will be generated using numbers from 1 to 63, divided into three groups denoting with letters A, B, and C. Randomization will be generated using (www.randomization.com).

Other: Cold matcha brew

Group C

ACTIVE COMPARATOR

21 participants. They will be generated using numbers from 1 to 63, divided into three groups denoting with letters A, B, and C. Randomization will be generated using (www.randomization.com).

Other: Water

Interventions

* Hot matcha brew will be prepared in usucha (thin consistency) version-2 grams of matcha powder (Dr.Baby) mixed with 30 mL of hot water (75 ̊C). The first step will be to massage the matcha powder with a small amount of water until a smooth paste forms, then additional 50 mL of hot water will be added to dilute down the concentration. The matcha will then be vigorously shaken in a lidded jar. * After 5 minutes of the acidic attack, participants will be instructed to swish 25 mL of matcha tea 34 times then swallow, and saliva samples will be collected (T2). * Then saliva will be collected after 10 (T3), 20 (T4), 30 (T5), and 40 (T6) minutes.

Group A
WaterOTHER

Water (elano) at 13 ̊C swished 34 times then swallowed.

Group C

25 mL of cold matcha brew prepared in usucha (thin consistency) version-2 grams of matcha powder (Dr.Baby) mixed with 80 mL of cold water (13 ̊C) swished 34 times then swallowed.

Group B

Eligibility Criteria

Age21 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Low caries-risk.
  • Medically healthy.
  • Have full permanent dentition.
  • Practice daily oral hygiene habits.

You may not qualify if:

  • Subjects who have active oral diseases as caries, periodontitis, gingivitis, or pulpitis.
  • Subjects who have oral-related pain as sensitivity, ulcers, or infection.
  • Subjects undergoing restorative or orthodontic treatment.
  • Subjects with salivary gland diseases.
  • Subjects with systemic diseases.
  • Subjects on medications that can affect the salivary gland function (antihistamines, anticancer drugs) in a period of at least two months before the start of the trial.
  • Subjects using antibiotics at the time of study or in the period of the last 15 days prior to the study.
  • Mouth breathing.
  • Smoking.
  • Pregnancy.
  • Subjects who did not give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Feeding Behavior

Interventions

Water

Condition Hierarchy (Ancestors)

Behavior, AnimalBehavior

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer

Study Record Dates

First Submitted

August 11, 2024

First Posted

August 20, 2024

Study Start

September 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 1, 2024

Last Updated

August 20, 2024

Record last verified: 2024-08