UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043182 |
|---|---|
| Receipt number | R000049288 |
| Scientific Title | Effect of tea gargling on periodontal tissue |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2025/03/31 18:07:33 |
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Basic information
Public title
Effect of tea gargling on periodontal tissue
Acronym
Tea and periodontal diseases
Scientific Title
Effect of tea gargling on periodontal tissue
Scientific Title:Acronym
Tea and periodontal diseases
Region
| Japan |
Condition
Condition
chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of tea gargling on periodontal tissue
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Clinical parameters related to periodontal diseases
e.g., probing pocket depth, clinical attachment loss, bleeding on probing, tooth mobility...
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -investigator(s) and assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
matcha green tea
Interventions/Control_2
barley tea
Interventions/Control_3
sodium azulene sulfonate
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
--patients who had finished initial periodontal therapy and were entering at the stage of supportive periodontal therapy
--patients who had at least one tooth having periodontal pockets with PPD more than 5 mm
Key exclusion criteria
--patients who had undergone antibiotic treatment in the last six months
--patients who were allergic to the components used in the treatments
--smoker at present
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Ryoma |
| Middle name | |
| Last name | Nakao |
Organization
National Institute of Infectious Diseases
Division name
Department of Bacteriology I
Zip code
162-8640
Address
1-23-1, Toyama, Shinjuku, Tokyo, JPN
TEL
+81-3-5285-1111
ryoma73@nih.go.jp
Public contact
Name of contact person
| 1st name | Ryoma |
| Middle name | |
| Last name | Nakao |
Organization
National Institute of Infectious Diseases
Division name
Department of Bacteriology I
Zip code
162-8640
Address
1-23-1, Toyama, Shinjuku, Tokyo, JPN
TEL
+81-3-5285-1111
Homepage URL
ryoma73@nih.go.jp
Sponsor or person
Institute
National Institute of Infectious Diseases
Institute
Department
Personal name
Funding Source
Organization
Society of research in matcha green tea and health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Institute of Infectious Diseases
Address
1-23-1, Toyama, Shinjuku, Tokyo, JPN
Tel
+81-3-5285-1111
ryoma73@nih.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
日本大学松戸歯学部付属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
https://journals.asm.org/doi/10.1128/spectrum.03426-23
Publication of results
Published
Result
URL related to results and publications
https://journals.asm.org/doi/10.1128/spectrum.03426-23
Number of participants that the trial has enrolled
45
Results
In a clinical study to assess the microbiological and therapeutic effects of matcha mouthwash in patients with periodontitis, the P. gingivalis number in saliva was significantly reduced by matcha mouthwash compared to the pre-intervention level. A tendency toward improvement in probing pocket depth was observed in the matcha group, although the difference was not statistically significant.
Results date posted
| 2025 | Year | 03 | Month | 31 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients with chronic periodontitis were assessed for eligibility at the Department of Periodontology (Nihon University Hospital School of Dentistry at Matsudo, Japan) between March 2021 and February 2022. Forty-five subjects who fulfilled the inclusion criteria were enrolled and randomly divided into the following three different groups: sodium azulene sulfonate hydrate, barley tea, or matcha. Inclusion criteria are as follows:
1. Patients with at least one tooth having PPD not less than 5 mm after completion of initial periodontal therapy
2. No antimicrobial treatment in the last 3 months
3. No smoking experience
4. No allergy experience
5. Not younger than 20 years old
Participant flow
Patients received one of the three powders containing sodium azulene sulfonate hydrate, barley tea, or matcha. They dissolved the powder by themselves in tap water to prepare the mouthwash and gargled the mouthwash twice a day for a month, according to a trained periodontist's instructions. Oral examination was performed and saliva samples were collected before and after the intervention. All 45 patients enrolled in the present study were followed up and analyzed. At the visit after intervention, we checked the records of individual administration, as well as interviewed the patients regarding whether mouth washing was properly performed. Adverse events were also documented with respect to onset, duration, treatment, relation to study medication, and outcome.
Adverse events
Nothing in particular
Outcome measures
The primary endpoint of this study was improvement of the following oral examination parameters by the intervention: Pl.I., GI, PPD, BOP, PISA, and PESA. The secondary endpoints were clearance of oral pathobionts in the oral cavity after the 1-month mouthwash intervention.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 01 | Month | 13 | Day |
Date of IRB
| 2021 | Year | 01 | Month | 13 | Day |
Anticipated trial start date
| 2021 | Year | 03 | Month | 30 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 01 | Month | 29 | Day |
Last modified on
| 2025 | Year | 03 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049288
