Back to resultsEvaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
Primary Purpose
Gingival Disease
Status
Active
Phase
Not Applicable
Locations
Iraq
Study Type
Interventional
Intervention
green tea
matcha tea
Sponsored by
About this trial
This is an interventional treatment trial for Gingival Disease
Eligibility Criteria
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.
Sites / Locations
- Universality of Baghdad, College of dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
green tea group
matcha tea group
Arm Description
Mahmood Green Tea Sri Lanka. It will be given 2 cups / day for 30 days.
Jade Leaf Organic Japanese Matcha, USA. It will be given 2 cups / day for 30 days.
Outcomes
Primary Outcome Measures
change in salivary level of antioxidant marker
change in level of catalase enzyme in ku/L
change in salivary level of ant-inflammatory marker
change in level of interleukin- one beta (IL-1B) in pg/L
Secondary Outcome Measures
change in percentage of bleeding on probing (BOP)
change in BOP percentage. less percentage means less inflammation in gingival tissue
change in plaque index (PI) scores
change in PI scores. less scores mean less dental plaque accumulated onto teeth surfaces
Full Information
NCT ID
NCT05681325
First Posted
December 11, 2022
Last Updated
January 11, 2023
Sponsor
Hayder Raad Abdulbaqi
1. Study Identification
Unique Protocol Identification Number
NCT05681325
Brief Title
Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
Official Title
Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 25, 2022 (Actual)
Primary Completion Date
April 12, 2023 (Anticipated)
Study Completion Date
July 12, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Hayder Raad Abdulbaqi
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingival Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
green tea group
Arm Type
Active Comparator
Arm Description
Mahmood Green Tea Sri Lanka. It will be given 2 cups / day for 30 days.
Arm Title
matcha tea group
Arm Type
Experimental
Arm Description
Jade Leaf Organic Japanese Matcha, USA. It will be given 2 cups / day for 30 days.
Intervention Type
Dietary Supplement
Intervention Name(s)
green tea
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
matcha tea
Intervention Description
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.
Primary Outcome Measure Information:
Title
change in salivary level of antioxidant marker
Description
change in level of catalase enzyme in ku/L
Time Frame
30 Days (baseline to one moth of tea intake)
Title
change in salivary level of ant-inflammatory marker
Description
change in level of interleukin- one beta (IL-1B) in pg/L
Time Frame
30 Days (baseline to one moth of tea intake)
Secondary Outcome Measure Information:
Title
change in percentage of bleeding on probing (BOP)
Description
change in BOP percentage. less percentage means less inflammation in gingival tissue
Time Frame
30 Days (baseline to one moth of tea intake)
Title
change in plaque index (PI) scores
Description
change in PI scores. less scores mean less dental plaque accumulated onto teeth surfaces
Time Frame
30 Days (baseline to one moth of tea intake)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
HIND KAREEM, BDS
Organizational Affiliation
University of Baghdad
Official's Role
Study Director
Facility Information:
Facility Name
Universality of Baghdad, College of dentistry
City
Baghdad
Country
Iraq
12. IPD Sharing Statement
Citations:
PubMed Identifier
34001101
Citation
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.
Results Reference
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PubMed Identifier
31832980
Citation
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.
Results Reference
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Evaluation of Antioxidant and Anti-inflammatory Effect of Matcha Tea Intake on Periodontal Health
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