UMIN-CTR Clinical Trial

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
Last 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
1st 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