NCT05681325

Brief Summary

Aim of the study: This study aims to evaluate the antioxidant and beneficial effects of matcha tea daily intake on periodontal health. Objectives:

  • To evaluate the salivary level of antioxidants (catalase, total antioxidant capacity) after matcha tea intake compared to green tea over a period of one month.
  • To evaluate the clinical periodontal parameters including bleeding on probing (BOP), probing pocket depth (PPD) and plaque index (PI) after matcha tea intake compared to green tea over a period of one month.
  • To evaluate the salivary levels of IL-1B after matcha tea intake compared to green tea over a period of one month.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 25, 2022

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2023

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 12, 2024

Completed
Last Updated

December 27, 2023

Status Verified

December 1, 2023

Enrollment Period

1.9 years

First QC Date

December 11, 2022

Last Update Submit

December 22, 2023

Conditions

Gingival Disease

Outcome Measures

Primary Outcomes (2)

  • change in salivary level of antioxidant marker

    change in level of catalase enzyme in ku/L

    30 Days (baseline to one moth of tea intake)

  • change in salivary level of ant-inflammatory marker

    change in level of interleukin- one beta (IL-1B) in pg/L

    30 Days (baseline to one moth of tea intake)

Secondary Outcomes (2)

  • change in percentage of bleeding on probing (BOP)

    30 Days (baseline to one moth of tea intake)

  • change in plaque index (PI) scores

    30 Days (baseline to one moth of tea intake)

Study Arms (2)

green tea group

ACTIVE COMPARATOR

Mahmood Green Tea Sri Lanka. It will be given 2 cups / day for 30 days.

Dietary Supplement: green tea

matcha tea group

EXPERIMENTAL

Jade Leaf Organic Japanese Matcha, USA. It will be given 2 cups / day for 30 days.

Dietary Supplement: matcha tea

Interventions

green teaDIETARY_SUPPLEMENT

It will be given 2 cups / day for 30 days. To prepare each cup, a tea pack will be immersed into a cup of hot water.

green tea group
matcha teaDIETARY_SUPPLEMENT

It will be given 2 cups / day for 30 days. To prepare each cup, a tea pack will be immersed into a cup of hot water.

matcha tea group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • having at least 20 teeth,
  • underwent no medical treatment during the last 3 months before examination and sampling,
  • non-smoker,
  • no history of systemic disease,
  • gingivitis patient (having \>10% bleeding sites with no PPD \>3 mm).

You may not qualify if:

  • wore orthodontic appliances,
  • pregnant or currently in the breast-feeding period,
  • periodontitis patient,
  • smoker,
  • has a history of systemic disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universality of Baghdad, College of dentistry

Baghdad, Iraq

Location

Related Publications (2)

  • Zhang Y, Kang N, Xue F, Qiao J, Duan J, Chen F, Cai Y. Evaluation of salivary biomarkers for the diagnosis of periodontitis. BMC Oral Health. 2021 May 17;21(1):266. doi: 10.1186/s12903-021-01600-5.

    PMID: 34001101BACKGROUND

  • Kolackova T, Kolofikova K, Sytarova I, Snopek L, Sumczynski D, Orsavova J. Matcha Tea: Analysis of Nutritional Composition, Phenolics and Antioxidant Activity. Plant Foods Hum Nutr. 2020 Mar;75(1):48-53. doi: 10.1007/s11130-019-00777-z.

    PMID: 31832980BACKGROUND

MeSH Terms

Conditions

Gingival Diseases

Interventions

Tea

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

  • HIND KAREEM, BDS

    University of Baghdad

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

December 11, 2022

First Posted

January 12, 2023

Study Start

January 25, 2022

Primary Completion

December 30, 2023

Study Completion

July 12, 2024

Last Updated

December 27, 2023

Record last verified: 2023-12

Locations

IR(1)