- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05681325
Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
December 22, 2023 updated by: Hayder Raad Abdulbaqi
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.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
40
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
-
-
-
Baghdad, Iraq
- Universality of Baghdad, College of dentistry
-
-
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 40 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
• 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).
Exclusion Criteria:
• wore orthodontic appliances,
- pregnant or currently in the breast-feeding period,
- periodontitis patient,
- smoker,
- has a history of 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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: green tea group
Mahmood Green Tea Sri Lanka.
It will be given 2 cups / day for 30 days.
|
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.
|
|
Experimental: matcha tea group
Jade Leaf Organic Japanese Matcha, USA.
It will be given 2 cups / day for 30 days.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in salivary level of antioxidant marker
Time Frame: 30 Days (baseline to one moth of tea intake)
|
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
Time Frame: 30 Days (baseline to one moth of tea intake)
|
change in level of interleukin- one beta (IL-1B) in pg/L
|
30 Days (baseline to one moth of tea intake)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in percentage of bleeding on probing (BOP)
Time Frame: 30 Days (baseline to one moth of tea intake)
|
change in BOP percentage.
less percentage means less inflammation in gingival tissue
|
30 Days (baseline to one moth of tea intake)
|
|
change in plaque index (PI) scores
Time Frame: 30 Days (baseline to one moth of tea intake)
|
change in PI scores.
less scores mean less dental plaque accumulated onto teeth surfaces
|
30 Days (baseline to one moth of tea intake)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: HIND KAREEM, BDS, University of Baghdad
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.
General Publications
- 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.
- 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.
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)
January 25, 2022
Primary Completion (Estimated)
December 30, 2023
Study Completion (Estimated)
July 12, 2024
Study Registration Dates
First Submitted
December 11, 2022
First Submitted That Met QC Criteria
January 11, 2023
First Posted (Actual)
January 12, 2023
Study Record Updates
Last Update Posted (Estimated)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 22, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- matcha on periodontal health
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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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