UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000035540
Receipt number 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 23:08:54

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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 or person

Institute

Tokyo Medical and Dental University

Institute

Department

Personal name



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

Value
https://center6.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