UMIN-CTR Clinical Trial
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|Unique ID issued by UMIN||UMIN000006791|
|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|
|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)|
(intrabony defect with probing depths more than 4mm)
|Classification by specialty||
|Classification by malignancy||Others|
|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 objectives -Others|
|Developmental phase||Not applicable|
|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.|
|Blinding||Double blind -all involved are blinded|
|Institution consideration||Institution is considered as a block.|
|Concealment||No need to know|
|No. of arms||2|
|Purpose of intervention||Treatment|
|Type of intervention||
|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.
|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.|
|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||
|Organization||AZABU NAKASUJI DENTAL CLINIC|
|Division name||AZABU NAKASUJI DENTAL CLINIC|
|Address||2-10-10 MinamiAzabu, Minato-ku, Tokyo, Japan|
|Name of contact person||
|Division name||Medical Science Information Center|
|Address||89-1 Yamashita-Cho, Naka-ku, Yokohama-shi, Kanagawa. Japan|
|Institute||AZABU NAKASUJI DENTAL CLINIC|
|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.
|Category of Funding Organization||Profit organization|
|Nationality of Funding Organization|
|Other related organizations|
|Name of secondary funder(s)|
|IRB Contact (For public release)|
|Org. issuing International ID_1|
|Org. issuing International ID_2|
|IND to MHLW|
|Other administrative information|
|Date of disclosure of the study information||
|URL releasing protocol|
|Publication of results||Published|
|URL related to results and publications|
|Number of participants that the trial has enrolled|
|Results date posted|
|Results Delay Reason|
|Date of the first journal publication of results|
|Plan to share IPD|
|IPD sharing Plan description|
|Date of protocol fixation||
|Date of IRB|
|Anticipated trial start date||
|Last follow-up date||
|Date of closure to data entry|
|Date trial data considered complete|
|Date analysis concluded|
|Other related information|
|Last modified on||
|Link to view the page|