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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005309
Receipt No. R000006314
Scientific Title A double-blind, randomized controlled pilot study of olive leaf extracts(OLE) for the prevention of periodontal diseases.
Date of disclosure of the study information 2011/03/25
Last modified on 2012/04/26

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Basic information
Public title A double-blind, randomized controlled pilot study of olive leaf extracts(OLE) for the prevention of periodontal diseases.
Acronym Pilot study of OLE for the prevention of periodontal diseases.
Scientific Title A double-blind, randomized controlled pilot study of olive leaf extracts(OLE) for the prevention of periodontal diseases.
Scientific Title:Acronym Pilot study of OLE for the prevention of periodontal diseases.
Region
Japan

Condition
Condition Periodontal diseases
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effect of OLE intake for the prevention of periodontal diseases is evaluated. The clinical indicies and cytokines in gingival crevicular fluid(GCF) are assessed as outcome measures.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Probing pocket depth(PPD), Gingival index(GI), Bleeding on probing(BOP)
Key secondary outcomes Remaining teeth, Clinical attachment level, Plaque index, Cytokines in GCF

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 300mg OLE intake group
Take 2 tablets of 100mg OLE 3 times a day before meal
Interventions/Control_2 600mg OLE intake group
Take 2 tablets of 200mg OLE 3 times a day before meal
Interventions/Control_3 Placebo group
Take 2 placebo tablets 3 times a day before meal
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
20 years-old <=
Age-upper limit
49 years-old >=
Gender Male and Female
Key inclusion criteria Those who have average PPD between 2mm and 4mm
Those who have average GI greater than 0
Age from 20 to 49
Those who have at least 20 teeth
Key exclusion criteria Those who took periodontal surgical therapy within 6 months
Those who are pregnant or lactating
Those who have a history of systematic diseases
Those who took antibiotics within 3 months
Those who took anti-inflammatory drugs within 2 weeks
Those who have unrestored caries
Those who smoke within 6 months
Those who participate in other clinical trial
Those who are judged not eligible for the study subjects by their investigators
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hideki Nagata
Organization Osaka University Graduate School of Dentistry
Division name Department of Preventive Dentistry
Zip code
Address 1-8 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2922
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hideki Nagata
Organization Osaka University Graduate School of Dentistry
Division name Department of Preventive Dentistry
Zip code
Address 1-8 Yamadaoka, Suita, Osaka, Japan
TEL 06-6879-2922
Homepage URL
Email nagatah@dent.osaka-u.ac.jp

Sponsor
Institute Department of Preventive Dentistry, Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Sunstar 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 NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 大阪大学歯学部附属病院

Other administrative information
Date of disclosure of the study information
2011 Year 03 Month 25 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
2011 Year 03 Month 24 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 03 Month 25 Day
Last modified on
2012 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006314

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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