UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013850
Receipt number R000016157
Scientific Title Assessment of the effect of administration of propolis and curry leaf into periodontal pockets on oral microbiota
Date of disclosure of the study information 2014/05/01
Last modified on 2015/08/03 14:32:31

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Basic information

Public title

Assessment of the effect of administration of propolis and curry leaf into periodontal pockets on oral microbiota

Acronym

Assessment of the effect of propolis and curry leaf on oral microbiota

Scientific Title

Assessment of the effect of administration of propolis and curry leaf into periodontal pockets on oral microbiota

Scientific Title:Acronym

Assessment of the effect of propolis and curry leaf on oral microbiota

Region

Japan


Condition

Condition

Chronic periodontitis

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To assess the effect of propolis and curry leaf on oral microbiota

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

periodontal pocket depth
quantity and quality of oral microbiota

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Double blind -all involved are blinded

Control

Active

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

4

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intervention-1: Placebo administration

Interventions/Control_2

Intervention-2: Minocycline administration

Interventions/Control_3

Intervention-3: Curry leaf administration

Interventions/Control_4

Intervention-4: Propolis administration

Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit


Not applicable

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Moderate periodontitis

Key exclusion criteria

Experience of taking any antibiotics within 6 months

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Ryoma Nakao

Organization

National Institute of Infectious Diseases

Division name

Department of Bacteriology I

Zip code


Address

1-23-1, Toyama, Shinjuku, Tokyo

TEL

03-5285-1111

Email

ryoma73@nih.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Ryoma Nakao

Organization

National Institute of Infectious Diseases

Division name

Department of Bacteriology I

Zip code


Address

1-23-1, Toyama, Shinjuku, Tokyo

TEL

03-5285-1111

Homepage URL


Email

ryoma73@nih.go.jp


Sponsor or person

Institute

National Institute of Infectious Diseases

Institute

Department

Personal name



Funding Source

Organization

Yamada Reseach Grant
and
Urakami Foundation

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization



Other related organizations

Co-sponsor

Departmentof Periodontology, Nihon University School of Dentistry at Matsudo

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

日本大学松戸歯学部付属病院歯周科(Department of Periodontology, Nihon University Hospital School of Dentistry at Matsudo)


Other administrative information

Date of disclosure of the study information

2014 Year 05 Month 01 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

2014 Year 04 Month 30 Day

Date of IRB


Anticipated trial start date

2014 Year 06 Month 01 Day

Last follow-up date

2015 Year 04 Month 18 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 30 Day

Last modified on

2015 Year 08 Month 03 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016157


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name