UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018867 |
|---|---|
| Receipt number | R000021822 |
| Scientific Title | Effects of highly-bioavailable curcumin for periodontitis: a randomized, double-blind, placebo-controlled prospective study |
| Date of disclosure of the study information | 2015/08/31 |
| Last modified on | 2019/02/04 16:03:10 |
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Basic information
Public title
Effects of highly-bioavailable curcumin for periodontitis: a randomized, double-blind, placebo-controlled prospective study
Acronym
Effects of curcumin for periodontitis
Scientific Title
Effects of highly-bioavailable curcumin for periodontitis: a randomized, double-blind, placebo-controlled prospective study
Scientific Title:Acronym
Effects of curcumin for periodontitis
Region
| Japan |
Condition
Condition
Chronic periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of study is to determine the clinical effects of orally administered Theracurmin in patients with chronic periodontitis.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase II
Assessment
Primary outcomes
Probing pocket depth
Clinical attachment level
Bleeding on probing
Gingival index
Plaque index
Tooth mobility
(Baseline, 1 and 2 month after baseline)
Key secondary outcomes
IL-1beta
TNF-alpha
IL-6
(Baseline, 2 month after baseline)
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 not considered as adjustment factor.
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Inrervention-1: Theracurmin
(contained 180mg of curcumin)
Interventions/Control_2
Intervention-2: Placebo administration
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
| 40 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Individuals with chronic periodontitis patients with periodontal pocket from 5 to 7mm.
Key exclusion criteria
1.Individuals with severe systemic deisease.
2. Individuals who are or suspected to be pregnant.
3. Individuals who take antiplatelet drug
4. Experience of taking any antibiotics within 6 months
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuichi Izumi |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku Tokyo 113-8549, Japan
TEL
03-5803-5488
y-izumi.peri@tmd.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | akizuki tatsuya |
Organization
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name
Department of Periodontology
Zip code
Address
1-5-45 Yushima, Bunkyo-ku Tokyo 113-8549, Japan
TEL
03-5803-5488
Homepage URL
akizuki.peri@tmd.ac.jp
Sponsor or person
Institute
Department of Periodontology
Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Theravalues Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1.Department of Periodontology, Tokyo Dental college
2.Department of Periodontology, Division of oral science, Kanagawa dental university
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
東京医科歯科大学（東京都）、東京歯科大学（東京都）、神奈川歯科大学（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 31 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 30 | 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
| 2015 | Year | 08 | Month | 31 | Day |
Last modified on
| 2019 | Year | 02 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021822
