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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000036691
Receipt No. R000041812
Scientific Title Foods high in melinjo resveratrol in the treatment of mild periodontitis patients
Date of disclosure of the study information 2019/05/09
Last modified on 2019/05/09

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Basic information
Public title Foods high in melinjo resveratrol in the treatment of mild periodontitis patients
Acronym Foods high in melinjo resveratrol in the treatment of mild periodontitis patients
Scientific Title Foods high in melinjo resveratrol in the treatment of mild periodontitis patients
Scientific Title:Acronym Foods high in melinjo resveratrol in the treatment of mild periodontitis patients
Region
Japan

Condition
Condition Periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The main purpose of the study is to evaluate the effect of melinjo resveratrol on not treated mild periodontitis patients.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following clinical parameters are recorded at each visit (baseline, week2, week4): (1) pocket depth(PD); (2) clinical attachment level (CAL); (3) bleeding on probing (BOP)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Patients will receive 150mg of melinjo resveratrol for 4 weeks.
Interventions/Control_2 Patients will receive 150mg of placebo for 4 weeks.
Interventions/Control_3
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
30 years-old <=
Age-upper limit
59 years-old >=
Gender Male and Female
Key inclusion criteria (1) Mild periodontitis patients;(2) Never had a periodontitis treatment before; (3) Non-smoker; (4)Bleeding on probing 10-30%; (5) no use of systemic antibiotics or oral anti-microbial agents within the past six months;
Key exclusion criteria (1)severe systemic disease; (2) pregnancy.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yuichi
Middle name
Last name Ikeda
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code 113-8510
Address Yushima 1-5-45 Bunkyo tokyo JAPAN
TEL 03-5803-5488
Email iwata.peri@tmd.ac.jp

Public contact
Name of contact person
1st name Yuichi
Middle name
Last name Ikeda
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code 113-8510
Address Yushima 1-5-45 Bunkyo tokyo JAPAN
TEL 03-5803-5488
Homepage URL
Email ikeda.peri@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization HOSODA SHC CO. LTD.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tokyo Medical and Dental University
Address Yushima 1-5-45 Bunkyo tokyo JAPAN
Tel 03-5803-5488
Email ikeda.peri@tmd.ac.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 東京医科歯科大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2019 Year 05 Month 09 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 05 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 07 Month 01 Day
Last follow-up date
2020 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 05 Month 09 Day
Last modified on
2019 Year 05 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041812

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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