UMIN-CTR Clinical Trial

Public title

Study on the effect of L8020 chocolate on oral condition

Acronym

Study on the effect of L8020 chocolate on oral condition

Scientific Title

Study on the effect of L8020 chocolate on oral condition

Scientific Title:Acronym

Study on the effect of L8020 chocolate on oral condition

Region

Japan

Condition

Healthy adult

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

The purpose of this study was to determine the impact of L8020-containing chocolate consumption on the oral environment.

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Primary outcomes

Gingival index
plaque control record
PD
PMA index
Oral bacterial count
Salivary Multi Test

Key secondary outcomes

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

L8020-containing chocolate group

Interventions/Control_2

placebo chocolate group

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

65

years-old

>

Gender

Male and Female

Key inclusion criteria

Healthy adults with treatment-free oral conditions

Key exclusion criteria

1. People who are allergic to dairy products and soybeans
2. People who are undergoing dental treatment at the time of registration
3. a person who has diabetes
4. History of cerebral infarction, neurological disease, head and neck area trauma or surgery
5. People who have consumed a product containing L8020 within 4 weeks before registration.
6.People who are taking classes of the principal investigator and research co-director
7.Any other person deemed inappropriate by the principal investigator or research co-investigator


Translated with www.DeepL.com/Translator (free version)

Target sample size

50

Name of lead principal investigator

1st name	MARIKO
Middle name
Last name	NAITO

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Oral Epidemiology

Zip code

7348553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

TEL

082-257-5959

Email

naitom@hiroshima-u.ac.jp

Name of contact person

1st name	RUMI
Middle name
Last name	NISHIMURA

Organization

Graduate School of Biomedical and Health Sciences, Hiroshima University

Division name

Oral Epidemiology

Zip code

7348553

Address

1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

TEL

082-257-5795

Homepage URL

Email

r-nishimura@hiroshima-u.ac.jp

Institute

Hiroshima University

Institute

Department

Personal name

Organization

Hiroshima University

Organization

Division

Category of Funding Organization

Government offices of other countries

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Hiroshima University hospital IRB

Address

1-2-3, Kasumi, Minami-ku, Hiroshima, 734-8551, Japan

Tel

082-257-5596

Email

hugcp@hiroshima-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

06

Month

17

Day

URL releasing protocol

https://mol.medicalonline.jp/library/journal/download?GoodsID=ds1denhy/2021/s01601/128&name=0119-011

Publication of results

Partially published

URL related to results and publications

https://mol.medicalonline.jp/library/journal/download?GoodsID=ds1denhy/2021/s01601/128&name=0119-011

Number of participants that the trial has enrolled

34

Results

In the L8020 group, PESA significantly decreased after 2 and 4 weeks, and PCR and PISA significantly decreased after 4 weeks compared to preintervention (p<0.001). There was a significant difference in PESA change between food groups before and after 2 weeks of intervention (p=0.008). The results of the evaluation of the effect of chocolate containing L8020 lactobacillus metabolites on the oral environment indicated the possibility of improving periodontal tissue condition.

Results date posted

2023

Year

06

Month

20

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

In this study, the research subjects were selected from among faculty and staff working at Hiroshima University or students attending Hiroshima University who met all of the following selection criteria and did not meet any of the exclusion criteria.
1) Selection criteria
1) Age at the time of consent: 20 years or older but less than 65 years old.
2) Those who have an oral condition that does not require medical treatment.
(iii) Persons whose consent to participate in this study was obtained in writing.
2) Exclusion criteria
1) Subjects with allergies to dairy products and soy
2) Patients undergoing dental treatment at the time of enrollment
3) Patients with diabetes mellitus
4) Patients with a history of cerebral infarction, neurological disease, trauma or surgery in the head and neck region
(5) Those who have consumed L8020-containing products within 4 weeks prior to enrollment.
(vi) Persons who are taking classes from the principal investigator and the research assistant.
(vii) Other subjects deemed inappropriate by the principal investigator or research assistant.

Participant flow

The research method was to have the subjects use L8020 chocolate (DOSHISHA Co., Ltd., Tokyo) and placebo chocolate (DOSHISHA Co., Ltd., Tokyo) containing no L8020 lactobacilli for 4 weeks each with a 4-week pause in between. At the beginning of each chocolate consumption, 2 weeks after consumption, at the end of consumption, and 2 weeks after the end of consumption, a total of 7 times, a saliva test and a dental checkup were conducted by the same nationally certified dental hygienist, who filled out a checkup form and took intraoral photographs. A questionnaire was also administered at the beginning of the intervention. The study design was a placebo-controlled, randomized, double-blind, crossover controlled trial and exploratory study of the subjects and the nationally certified dental hygienist performing the examinations

Adverse events

None

Outcome measures

1) Present dental status: Present dental and caries status
2) Basic information of study subjects (sex, date of birth, age, oral cleaning habits, snacking habits): questionnaire survey
3) Oral cleaning status: O'Leary's Plaque Control Record (PCR)
4) Periodontal tissue condition: periodontal epithelial surface area (PESA), periodontal inflamed surface area (PISA), PMA Index
5) Bacterial count status

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2020

Year

06

Month

10

Day

Date of IRB

2020

Year

06

Month

17

Day

Anticipated trial start date

2020

Year

06

Month

17

Day

Last follow-up date

2022

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2020

Year

06

Month

17

Day

Last modified on

2023

Year

06

Month

20

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045832