UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006791 |
|---|---|
| Receipt number | R000008033 |
| Scientific Title | Effect of supplement jelly intake basic treatment of periodontal disease: Randomized placebo controlled study. (ESTOP Study) |
| Date of disclosure of the study information | 2011/11/30 |
| Last modified on | 2015/12/15 11:19:44 |
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Basic information
Public title
Effect of supplement jelly intake basic treatment of periodontal disease: Randomized placebo controlled study. (ESTOP Study)
Acronym
Effect of supplement jelly intake basic treatment of periodontal disease: Randomized placebo controlled study. (ESTOP Study)
Scientific Title
Effect of supplement jelly intake basic treatment of periodontal disease: Randomized placebo controlled study. (ESTOP Study)
Scientific Title:Acronym
Effect of supplement jelly intake basic treatment of periodontal disease: Randomized placebo controlled study. (ESTOP Study)
Region
| Japan |
Condition
Condition
Periodontal diseases
(intrabony defect with probing depths more than 4mm)
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Effect of supplement jelly intake in basic treatment of periodontal disease.
The primary outcomes of this study are to evaluate the probing pocket depth (PD) and bleeding on probing (BOP).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Probing pocket depth (PD)
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 considered as a block.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Supplement jelly group
Take supplement jelly in one bag of once a day between after supper and before bedtime.
Interventions/Control_2
Placebo jelly group
Take placebo jelly in one bag of once a day between after supper and before bedtime.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)Patients having probing depths more than 4mm.
2)The day of agreement for this study is 20 years or older (gender-free).
3)All patients gave written informed consent.
Key exclusion criteria
1)Patients gave the surgical periodontal disease treatment and antibiotic within 3 months.
2)Relevaant medical conditions contraindicating surgical interventions(e.g., diabetes mellittus, autoimmune disease )
3)Patient takes a supplement including the ingredient same as a experimental diet or pharmaceutical agent.
4)Patients are judged not eligible for this study by investigator.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuko Nakasuji |
Organization
AZABU NAKASUJI DENTAL CLINIC
Division name
AZABU NAKASUJI DENTAL CLINIC
Zip code
Address
2-10-10 MinamiAzabu, Minato-ku, Tokyo, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toshinori Noguchi |
Organization
FANCL Corporation
Division name
Medical Science Information Center
Zip code
Address
89-1 Yamashita-Cho, Naka-ku, Yokohama-shi, Kanagawa. Japan
TEL
045-226-1302
Homepage URL
noguchi_toshinori@fancl.co.jp
Sponsor or person
Institute
AZABU NAKASUJI DENTAL CLINIC
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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
麻布なかすじデンタルクリニック(東京都)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 11 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 11 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2011 | Year | 11 | Month | 29 | Day |
Last modified on
| 2015 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008033
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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