UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of highly-bioavailable curcumin for periodontitis: a randomized, double-blind, placebo-controlled prospective study
Title of the study (Brief title)	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	Yuichi Izumi
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima, Bunkyo-ku Tokyo 113-8549, Japan
TEL	03-5803-5488
Email	y-izumi.peri@tmd.ac.jp

Public contact
Name of contact person	akizuki tatsuya
Organization	Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Division name	Department of Periodontology
Address	1-5-45 Yushima, Bunkyo-ku Tokyo 113-8549, Japan
TEL	03-5803-5488
Homepage URL
Email	akizuki.peri@tmd.ac.jp

Sponsor
Institute	Department of Periodontology Graduate School of Medical and Dental Sciences, Tokyo Medical and Dental University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021822