UMIN-CTR Clinical Trial

Basic information
Public title	A verification study of improving on the oral cavity environment with consumption of the test food
Acronym	A verification study of improving on the oral cavity environment with consumption of the test food
Scientific Title	A verification study of improving on the oral cavity environment with consumption of the test food: a randomized, double-blind, placebo-controlled, parallel-group trial
Scientific Title:Acronym	A verification study of improving on the oral cavity environment with consumption of the test food
Region	Japan

Condition
Condition	Periodontosis
Classification by specialty	Dental medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To exploratory verify the effects of consumption of the test food for four weeks on the oral cavity environment in Japanese subjects who are diagnosed with periodontitis.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The measured values of T.forsythensis at four weeks after the start of test-food consumption (4w) 2. The logarithmic values of T.forsythensis at 4w 3. The ratio of T.forsythensis to total bacteria at 4w 4. The amount of changes in items 1 to 3 above from before intake to 4w
Key secondary outcomes	1. The measured values, logarithmic values, and the ratio to total bacteria of A.actinomycetemcomitans, P.gingivalis, P.intermedia, T.denticola, F.nucleatum and the amount of changes of these items from before intake to 4w. 2. The measured values and changes of "halitosis," "swelling of gums," "surface roughness of tooth," "oral discomfort," "dry mouth," "stickiness in the mouth," "eye fatigue," and "blurred eyes" at 4w 3. The measured values and changes of serum and salivary IGF-1 levels at 4w 4. The measured values and changes of the number of S.mutans at 4w 5. The measured values and changes of Gingival Index and Plaque Index at 4w 6. The measured values and changes of bleeding on probing at 4w 7. The measured values and changes of depth of periodontal pockets at 4w 8. The measured values and changes of visual acuities of the average of both eyes and dominant/non-dominant eyes at 4w

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: Four weeks Test food: HGH crystal MD Administration: One pack, three times per day. Maintain the test food in the mouth for 40 seconds and swallow it before each meal.
Interventions/Control_2	Duration: Four weeks Test food: Placebo Administration: One pack, three times per day. Maintain the test food in the mouth for 40 seconds and swallow it before each meal.
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. Japanese males and females 2. Subjects who are diagnosed with periodontosis 3. Subjects who are judged as eligible to participate in the trial by the principal investigator 4. Subjects who have relatively high percentage of T.forsythensis in salivary test at the screening
Key exclusion criteria	1. Subjects undergoing medical treatment or having a medical history of malignant tumor, heart failure, or myocardial infarction 2. Subjects carrying a pacemaker or an implantable cardioverter defibrillator (ICD) 3. Subjects undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disease, kidney disease, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, metabolic syndrome, or any other chronic diseases 4. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", or other functional food/beverage as part of their daily intake 5. Subjects currently regularly taking medications (including herbal medicines) and supplements 6. Subjects who regularly use floss, interdental cleaner, and mouthwash 7. Subjects who have receiving dental maintenance care at dental clinic, such as removing dental plaques and dental tartars within the last three months 8. Subjects who are under treatment or diagnosed with any of dental diseases except for periodontosis 9. Subjects who are smokers, or started smoking cessation within a year before the invitation to participate in this trial 10. Subjects allergic to medications and/or the test-food-related products. Particularly, rye, wheat, oats, corn, rice, and soybean allergies. 11. Subjects who are lactating, pregnant, or intending to become pregnant 12. Subjects who have been enrolled in other clinical trials within the last three months before the invitation to participate in this trial, or plan to participate in another trial during this trial 13. Subjects who are judged by the principal investigator as ineligible to participate in the trial
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Masahiko Middle name Last name HORIUCHI
Organization	Medical Corporation Yuseikai, Horiuchi Dental Clinic
Division name	director
Zip code	141-0022
Address	2F AM Bldg., 2-3-3 Higashi-gotanda, Shinagawa-ku, Tokyo
TEL	03-3449-1033
Email	masa.37@nifty.com

Public contact
Name of contact person	1st name Naoko Middle name Last name SUZUKI
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Zip code	112-0002
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Autobahn Co. Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara Clinic
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Takara Clinic Certified Review Board
Address	9F Taisei Building, 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan.
Tel	03-5793-3623
Email	CRB@takara-clinic.com

Secondary IDs
Secondary IDs	YES
Study ID_1	jRCTs031190204
Org. issuing International ID_1	Japan Registry of Clinical Trials
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions	医療法人社団優正会 堀内歯科医院 (東京都) Medical Corporation Yuseikai, Horiuchi Dental Clinic (Tokyo, Japan) 医療法人社団盛心会 タカラクリニック (東京都) Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2020 Year 02 Month 17 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	40
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	2020 Year 01 Month 23 Day
Date of IRB	2020 Year 01 Month 24 Day
Anticipated trial start date	2020 Year 02 Month 17 Day
Last follow-up date	2020 Year 07 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 02 Month 17 Day
Last modified on	2021 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045012