NCT06504706

Brief Summary

Objectives: To evaluate the effect of green tea versus matcha tea on the salivary pH in high caries risk patients. Materials and methods: Total number of high caries risk patients were randomized into two equal groups (n=). Group 1 (intervention group) was given Matcha Tea and Group 2 (control group) was given green tea. A portable digital pH meter was used to measure the salivary pH at baseline and after consumption tea immediately, after 5 mins and after 10 mins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 1, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

July 10, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 17, 2024

Completed
Last Updated

July 17, 2024

Status Verified

July 1, 2024

Enrollment Period

6 months

First QC Date

July 10, 2024

Last Update Submit

July 15, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • salivary pH

    pH of saliva to be measured

    baseline before administration of tea, immediately after administration of tea, 5 minutes after administration of tea and 10 minutes after administration of tea

Study Arms (2)

Green Tea

ACTIVE COMPARATOR

Green tea contains a significant amount of catechins, which are subgroup of flavonoids and play a vital role in maintaining health having strong bactericidal as well as antibacterial activity

Procedure: Green Tea

Matcha Tea

EXPERIMENTAL

Matcha, powder of specially cultivated tea leaves, is gaining popularity in functional food and other food markets all over the world. Various studies have reported the difference in bioactive compounds in matcha as compared to green tea and other tea formulations

Procedure: Matcha Tea

Interventions

Matcha TeaPROCEDURE

Japanese tea rich in antioxidants and Catechins

Matcha Tea
Green TeaPROCEDURE

Green tea rich in catechins

Green Tea

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \. High caries risk patients
  • Satisfactory cooperative behavior
  • Age between 20-45 years old
  • Males or females
  • Subjects who signed informed consent

You may not qualify if:

  • \. Systemic diseases 2. Drug consumption during 3 past months 3. Salivary gland disorders 4. History of radiotherapy 5. Smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry Cairo University

Cairo, 12345, Egypt

Location

MeSH Terms

Interventions

Tea

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
participants will be blinded to the type of tea they are drinking and investigators will be blinded as well
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Controlled Trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

July 10, 2024

First Posted

July 17, 2024

Study Start

January 1, 2024

Primary Completion

July 1, 2024

Study Completion

July 1, 2024

Last Updated

July 17, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations