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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000020147
Receipt No. R000023271
Scientific Title Effect of melinjo seed extract containing resveratol for periodontitis
Date of disclosure of the study information 2015/12/11
Last modified on 2015/12/10

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Basic information
Public title Effect of melinjo seed extract containing resveratol for periodontitis
Acronym Effect of resveratol for periodontitis
Scientific Title Effect of melinjo seed extract containing resveratol for periodontitis
Scientific Title:Acronym Effect of resveratol for periodontitis
Region
Japan

Condition
Condition Chronic periodontitis
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of study is to determine the clinical effects of orally administered resveratol in patients with chronic periodontitis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Probing pocket depth
Clinical attachment level
Bleeding on probing
Gingival index
Plaque index
Tooth mobility
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 NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Resveratol
Interventions/Control_2 Placebo
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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Individuals with chronic periodontitis patients with peridontal pocket from 5 to 7 mm.
Key exclusion criteria 1. Individuals with severe systemic disease.
2. Individuals who are or suspected to be pregnant.
3. Experience of taking any antibiotics within 6 months.
Target sample size 70

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuichi Izumi
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku Tokyo 113-8549, Japan
TEL 03-5803-5488
Email y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tomonari Suda
Organization Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code
Address 1-5-45 Yushima, Bunkyo-ku Tokyo 113-8549, Japan
TEL 03-5803-5488
Homepage URL
Email sudaperi@tmd.ac.jp

Sponsor
Institute Department of Periodontology, Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Yamada Bee Farm
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
Address
Tel
Email

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

Other administrative information
Date of disclosure of the study information
2015 Year 12 Month 11 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
2015 Year 12 Month 11 Day
Date of IRB
Anticipated trial start date
2016 Year 01 Month 05 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 12 Month 10 Day
Last modified on
2015 Year 12 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023271

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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