UMIN-CTR Clinical Trial

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

Periodontosis

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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

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

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

Institute

ORTHOMEDICO Inc.

Institute

Department

Personal name

Organization

Autobahn Co. Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Medical Corporation Seishinkai, Takara Clinic

Name of secondary funder(s)

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

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

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)

Date of disclosure of the study information

2020

Year

02

Month

17

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2020

Year

02

Month

17

Day

Last modified on

2021

Year

04

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045012