- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06912958
Efficacy of Matcha Tea on Patients With Biofilm-induced Gingivitis
- Evaluate the salivary level of antioxidants (malondialdehyde "MDA," superoxide dismutase "SOD," and glutathione peroxidase-1 "GPX-1") by enzyme-linked immunosorbent assay test (ELISA).
- 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Gingivitis is the most common form of periodontal disease (PD). In a survey conducted in three Latin American cities, gingivitis was detected in approximately 99.6% of 1650 subjects. It is defined as inflammation affecting gingival tissue surrounding teeth. Clinically, it is characterized by gingival redness and edema with no periodontal attachment loss.
The generation of reactive oxygen species (ROS) and other free radicals (R) during metabolism is a normal process that ideally is compensated by an endogenous antioxidant system. However, due to many environmental, lifestyle, and pathological situations, excess radicals can accumulate, resulting in oxidative stress. Oxidative stress (OS) has been related to cardiovascular disease, cancer, and other chronic diseases. It also plays an important role in the pathogenesis of periodontal disease.
Inflammatory response is a part of many diseases. It may lead to the production of excessive amounts of substances promoting the production of reactive oxygen species (ROS), which can damage cell structures and lead to long-term disruption in the functioning of the body.
One solution to keeping the appropriate oxidative balance is a high supply of exogenic antioxidants that aims to equalize and prevent oxidative processes. It is also important to maintain a correct lifestyle, free from stress-inducing factors.
There are 3 main varieties of tea: green, black, and oolong. The difference is in how the teas are processed. Green tea is made from unfermented leaves and reportedly contains the highest concentration of powerful antioxidants called polyphenols.
Antioxidants are substances that fight free radicals, damaging compounds in the body that change cells, damage DNA, and even cause cell death. Antioxidants, such as polyphenols in green tea, can neutralize free radicals and may reduce or even help prevent some of the damage.
Matcha tea is Japanese powdered green tea that is derived from the Camellia sinensis plant, the same plant of green tea. It contains huge amounts of polyphenols, amino acids (mainly tannins), and caffeine that probably increase its antioxidant characteristic.
Matcha tea is planted and processed differently. First, during the cultivation, green tea is grown in the sun; however, matcha tea is grown under shadow during the last few weeks before harvesting. Therefore, this difference in cultivation procedure leads to a higher amount of theanine and polyphenols in the content of Matcha tea.
Matcha tea contains more than double the amount of vitamin C than green tea. Vitamin C is a powerful exogenous antioxidant that reinforces the immune defense of the body. Additionally, it helps to seal blood vessels, has anti-inflammatory properties, and also supports the immune system.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
City of medicine
-
Baghdad, City of medicine, Iraq, Alrafedain street
- Baghdad University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
*pregnant or in the period of breast feeding.
- smokers and alcoholics.
- Patients wearing orthodontic appliances.
- has history of systemic disease.
- periodontitis patient
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Matcha tea group
Intake of two cups daily for a month of matcha tea with oral hygiene instructions.
|
Japanese tea that will take twice daily for one month
dietary intake
Other Names:
|
|
No Intervention: Control group
Oral hygiene instructions, which include brushing teeth and flossing twice daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluate the antioxidant effects of Matcha tea in daily intake for gingivitis patients.
Time Frame: One month
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Measuring the changes in the clinical periodontal parameters
Time Frame: one month
|
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.
|
one month
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- (Carr A.C et al ,2017)
- (Jakubczyk K et al ,2020)
- (Lobo et al, 2010
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Matcha tea on gingivitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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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