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Recruitment status Completed
Unique ID issued by UMIN UMIN000035540
Receipt No. R000040494
Scientific Title Resveratrol derivative-rich melinjo seed extract in the treatment of chronic periodontitis patients A randomized controlled pilot study
Date of disclosure of the study information 2019/01/14
Last modified on 2019/01/14

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Basic information
Public title Resveratrol derivative-rich melinjo seed extract in the treatment of chronic periodontitis patients
A randomized controlled pilot study
Acronym Resveratrol in the treatment of periodontitis patients
Scientific Title Resveratrol derivative-rich melinjo seed extract in the treatment of chronic periodontitis patients
A randomized controlled pilot study
Scientific Title:Acronym Resveratrol in the treatment of periodontitis patients
Region
Japan

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

Objectives
Narrative objectives1 The aim of this study was to assess the effect of melinjo seed extract on patients who had been treated previously for periodontitis and were in supportive periodontal therapy.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The following clinical parameters were recorded at each visit (baseline, week4, week8): (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 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 Patients received 150mg of melinjo seed extract for 8 weeks.
Interventions/Control_2 Patients received 150mg of placebo for 8 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
40 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria (1) no use of systemic antibiotics or oral anti-microbial agents within the past six months; (2) periodontitis defined as the presence (on fully erupted teeth) of at least one site with a probing depth (PD) 5-7 mm;
Key exclusion criteria (1)severe systemic disease; (2) pregnancy.
Target sample size 18

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

Public contact
Name of contact person
1st name
Middle name
Last name Yuichi Ikeda
Organization Tokyo Medical and Dental University
Division name Department of Periodontology
Zip code
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 Yamada Bee Company, Inc.
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 YES
Study ID_1 1286
Org. issuing International ID_1 Tokyo Medical and Dental University Institutional Review Board
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions Tokyo Medical and Dental University

Other administrative information
Date of disclosure of the study information
2019 Year 01 Month 14 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 Completed
Date of protocol fixation
2016 Year 03 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 04 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 07 Month 31 Day

Other
Other related information

Management information
Registered date
2019 Year 01 Month 14 Day
Last modified on
2019 Year 01 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040494

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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