GingivitisNCT06912958
Efficacy of Matcha Tea on Patients With Biofilm-induced Gingivitis
A study testing Drinking of matcha tea and Organic Japanese Matcha, Jade Leaf, Japan in people with Gingivitis, run by Ahmed Talib at 1 site in Iraq.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 16 to 75 years
- Conditions the study is for
- Gingivitis
- What is being tested?
- Drinking of matcha tea and Organic Japanese Matcha, Jade Leaf, Japan
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIraq
- Study dates
- 17 Nov 2024to 4 Feb 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 75 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- *pregnant or in the period of breast feeding.
- smokers and alcoholics.
- Patients wearing orthodontic appliances.
- has history of systemic disease.
- periodontitis patient
Trial locations and contacts
1 site in 1 country.
About this study
- 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.
Read the 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.
- Conditions
- Gingivitis
- Being tested
- Drinking of matcha tea, Organic Japanese Matcha, Jade Leaf, Japan
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinking of matcha teaDietary supplement
Japanese tea that will take twice daily for one month
Organic Japanese Matcha, Jade Leaf, JapanDietary supplement
Also called Lot T47I10P100
dietary intake
| Study group | Role | What they receive |
|---|---|---|
| Matcha tea group | Experimental | Intake of two cups daily for a month of matcha tea with oral hygiene instructions. Receives: Dietary Supplement: Drinking of matcha tea; Dietary Supplement: Organic Japanese Matcha, Jade Leaf, Japan |
| Control group | No intervention | Oral hygiene instructions, which include brushing teeth and flossing twice daily. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: One month
Secondary outcomes (1)
Measuring the changes in the clinical periodontal parameters
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.
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2025
- Study start17 Nov 2024
- Primary completion27 Jan 2025
- Study completion4 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The first group recieve the drug A. While the second group will recieve drug B
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ahmed Talib
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ahmed Talib, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06912958
- Sponsor's protocol ID
- Matcha tea on gingivitis
- Status last verified
- Apr 2025
- First submitted
- 27 Mar 2025
- Last updated
- 6 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
(Carr A.C et al ,2017)
(Jakubczyk K et al ,2020)
(Lobo et al, 2010
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Matcha Tea on Patients With Biofilm-induced Gingivitis
- ClinicalTrials.gov ID
- NCT06912958
- Acronym / sponsor ID
- Matcha tea on gingivitis
- Conditions
- Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Ahmed TalibUniversity, hospital or other
- Study start
- 17 Nov 2024 (actual)
- Primary completion
- 27 Jan 2025 (actual)
- Study completion
- 4 Feb 2025 (actual)
- First posted
- 6 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The first group recieve the drug A. While the second group will recieve drug B
| Arm | Type | Receives |
|---|---|---|
| Matcha tea group | Experimental | Dietary Supplement: Drinking of matcha tea, Dietary Supplement: Organic Japanese Matcha, Jade Leaf, JapanIntake of two cups daily for a month of matcha tea with oral hygiene instructions. |
| Control group | No intervention | –Oral hygiene instructions, which include brushing teeth and flossing twice daily. |
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- *pregnant or in the period of breast feeding.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Drinking of matcha teaJapanese tea that will take twice daily for one month | Dietary supplement | Matcha tea group |
| Organic Japanese Matcha, Jade Leaf, JapanAlso: Lot T47I10P100dietary intake | Dietary supplement | Matcha tea group |
Primary outcome
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).
1 secondary outcome
Measuring the changes in the clinical periodontal parameters
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2025.
- Background(Carr A.C et al ,2017)
- Background(Jakubczyk K et al ,2020)
- Background(Lobo et al, 2010
- Individual participant dataSharing planned: No
Related trials for Gingivitis
Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Active, not recruitingPhase 3
A Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Established Dental Plaque and Gingivitis
Plaque, Gingivitis
Not yet recruiting
Effectiveness of Personalized Digital Oral Health Intervention in Patients With Fixed Orthodontic Appliances.
Oral Hygiene in Patients With Fixed Orthodontic Appliances, Dental Plaque
Not yet recruitingPhase 2
Efficacy of Thymus Vulgaris Mouthwash in the Management of Biofilm-Induced Gingivitis
Plaque-Induced Gingivitis
Not yet recruitingPhase 3
Periodontal Disease and Small Vulnerable Newborns in Rural Nepal: A Community-based Trial
Preterm Birth, Low Birth Weight
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinking of matcha tea and Organic Japanese Matcha, Jade Leaf, Japan in people with Gingivitis, run by Ahmed Talib at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the antioxidant effects of Matcha tea in daily intake for gingivitis patients. (time frame: One month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06912958, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2025.