NCT06912958

Brief Summary

  1. 1.Evaluate the salivary level of antioxidants (malondialdehyde "MDA," superoxide dismutase "SOD," and glutathione peroxidase-1 "GPX-1") by enzyme-linked immunosorbent assay test (ELISA).
  2. 2.Measuring clinical periodontal parameters, which are plaque index (PI), bleeding on probing (BOP), and gingival index (GI), between the baseline and endpoint of the study, which is one month.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 17, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2025

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2025

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2025

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

2 months

First QC Date

March 27, 2025

Last Update Submit

April 2, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Evaluate the antioxidant effects of Matcha tea in daily intake for gingivitis patients.

    Evaluate the salivary level of antioxidants (malondialdehyde "MDA," superoxide dismutase "SOD," and glutathione peroxidase-1 "GPX-1") by enzyme-linked immunosorbent assay test (ELISA).

    One month

Secondary Outcomes (1)

  • Measuring the changes in the clinical periodontal parameters

    one month

Study Arms (2)

Matcha tea group

EXPERIMENTAL

Intake of two cups daily for a month of matcha tea with oral hygiene instructions.

Dietary Supplement: Drinking of matcha teaDietary Supplement: Organic Japanese Matcha, Jade Leaf, Japan

Control group

NO INTERVENTION

Oral hygiene instructions, which include brushing teeth and flossing twice daily.

Interventions

Drinking of matcha teaDIETARY_SUPPLEMENT

Japanese tea that will take twice daily for one month

Matcha tea group

dietary intake

Also known as: Lot T47I10P100
Matcha tea group

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Having at least 20 teeth.
  • gingivitis patient ( BOP\<10% , PPD = or \<3mm , no CAL , Have plaque index =1 ( according to Quigley-hein plaque index )
  • No history of systemic disease.
  • No medical treatment that impact periodontal status at last 6 months before examination and sampling.
  • life style control

You may not qualify if:

  • \*pregnant or in the period of breast feeding.
  • smokers and alcoholics.
  • Patients wearing orthodontic appliances.
  • has history of systemic disease.
  • periodontitis patient

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baghdad university

Baghdad, City of Medicine, Alrafedain street, Iraq

Location

Related Publications (3)

  • (Carr A.C et al ,2017)

    BACKGROUND
  • (Jakubczyk K et al ,2020)

    BACKGROUND
  • (Lobo et al, 2010

    BACKGROUND

MeSH Terms

Conditions

Gingivitis

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: The first group recieve the drug A. While the second group will recieve drug B
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Clinical researcher

Study Record Dates

First Submitted

March 27, 2025

First Posted

April 6, 2025

Study Start

November 17, 2024

Primary Completion

January 27, 2025

Study Completion

February 4, 2025

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations