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Recruitment status Completed
Unique ID issued by UMIN UMIN000006791
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email

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
Email noguchi_toshinori@fancl.co.jp

Sponsor
Institute AZABU NAKASUJI DENTAL CLINIC
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008033


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