Gingival DiseaseNCT05681325
Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
A study testing green tea and matcha tea in people with Gingival Disease, run by Hayder Raad Abdulbaqi at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Disease
- What is being tested?
- green tea and matcha tea
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIraq
- Study dates
- 25 Jan 2022to 12 Jul 2024
- 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 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • 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).
Who cannot join
- • wore orthodontic appliances,
- pregnant or currently in the breast-feeding period,
- periodontitis patient,
- smoker,
- has a history of systemic disease.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Gingival Disease
- Being tested
- green tea, matcha tea
- Medical subject headings
- Gingival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| green tea group | Active comparator | Mahmood Green Tea Sri Lanka. It will be given 2 cups / day for 30 days. Receives: Dietary Supplement: green tea |
| matcha tea group | Experimental | Jade Leaf Organic Japanese Matcha, USA. It will be given 2 cups / day for 30 days. Receives: Dietary Supplement: matcha tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in salivary level of antioxidant marker
change in level of catalase enzyme in ku/L
Measured: 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
Measured: 30 Days (baseline to one moth of tea intake)
Secondary outcomes (2)
change in percentage of bleeding on probing (BOP)
change in BOP percentage. less percentage means less inflammation in gingival tissue
Measured: 30 Days (baseline to one moth of tea intake)
change in plaque index (PI) scores
change in PI scores. less scores mean less dental plaque accumulated onto teeth surfaces
Measured: 30 Days (baseline to one moth of tea intake)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2023
- Study start25 Jan 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion12 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Gingival DiseaseStudies 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
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hayder Raad Abdulbaqi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hayder Raad Abdulbaqi, University of Baghdad
- Investigators
- HIND KAREEM, BDS, Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05681325
- Sponsor's protocol ID
- matcha on periodontal health
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2022
- Last updated
- 27 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 34001101Kolackova 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.
PubMed 31832980
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
- ClinicalTrials.gov ID
- NCT05681325
- Acronym / sponsor ID
- matcha on periodontal health
- Conditions
- Gingival Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hayder Raad AbdulbaqiUniversity, hospital or other
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 12 Jul 2024 (estimated)
- First posted
- 12 Jan 2023 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| green tea group | Active comparator | Dietary Supplement: green teaMahmood Green Tea Sri Lanka. It will be given 2 cups / day for 30 days. |
| matcha tea group | Experimental | Dietary Supplement: matcha teaJade Leaf Organic Japanese Matcha, USA. It will be given 2 cups / day for 30 days. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- • having at least 20 teeth,
Key exclusion criteria (5 listed)
- • wore orthodontic appliances,
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 |
|---|---|---|
| green teaIt 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. | Dietary supplement | green tea group |
| matcha teaIt 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. | Dietary supplement | matcha tea group |
Primary outcome
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
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
2 secondary outcomes
change in percentage of bleeding on probing (BOP)
Time frame: 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2023.
- Background: PubMed 34001101Zhang 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.
- Background: PubMed 31832980Kolackova 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.
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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.
HIND KAREEM, BDS study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing green tea and matcha tea in people with Gingival Disease, run by Hayder Raad Abdulbaqi 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: status not confirmed, as of the sponsor's last update on 27 Dec 2023. 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?
Results are not available in the source record.
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?
change in salivary level of antioxidant marker (time frame: 30 Days (baseline to one moth of tea intake)). The study lists 2 primary outcomes in all. 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 NCT05681325, which also lists 2 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 27 Dec 2023.