UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000036691
Receipt number 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 21:18:14

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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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.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