UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005309 |
|---|---|
| Receipt number | 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 10:58:05 |
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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
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
nagatah@dent.osaka-u.ac.jp
Sponsor or person
Institute
Department of Preventive Dentistry, Osaka University Graduate School of Dentistry
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006314
