UMIN-CTR Clinical Trial

Public title

Change of salivary bacterial flora after oral cleaning in dentist.

Acronym

Elucidation of healthy salivary bacterial flora.

Scientific Title

Change of salivary microbiome in dentists after 6-week daily advanced oral self-care: A retrospective study for consideration of healthy salivary microbiome.

Scientific Title:Acronym

Elucidation of healthy salivary microbiome.

Region

Japan

Condition

Periodontal diseases

Classification by specialty

Dental medicine

Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Elucidation of healthy salivary microbiome.

Basic objectives2

Others

Basic objectives -Others

We have to understand Health to evaluate Diseases. We need further accumulation of comprehensions to establish the identity of the healthy oral microbiome. The aim of the study is to present the reliable healthy salivary microbiome.

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change of bacterial diversity after 6-week daily advanced oral self-care in salivary microbiome.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

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

28

years-old

<=

Age-upper limit

51

years-old

>=

Gender

Male and Female

Key inclusion criteria

Participation in previous interventional study to provide saliva samples.

Inclusion criteria in the previous interventional study.
- Being dentist.
- Having 24 functioning teeth or more.
- Being interested in the study.
- Awareness of oral and systemic own good health condition.
- Intention of adherence to an instructed oral self-care

Key exclusion criteria

Withdrawal from the study participation.

exclusion criteria in the previous interventional study.
- Positive for salivary occult blood test (Sunstar, Osaka, Japan).
- Necessity for dental treatment.
- Presence of a partially impacted tooth.
- Smoker.
- Pregnant or breast-feeding woman.
- Having used systemic antibiotics within the previous 3 months.
- Regular medication for any other chronic disease.
- Participation in another clinical trial.

Target sample size

8

Name of lead principal investigator

1st name	Nobuhiro
Middle name
Last name	Hanada

Organization

Tsurumi University

Division name

School of Dental Medicine

Zip code

230-8501

Address

2-1-3 Tsurumi, Yokohama Japan

TEL

0455808461

Email

hanada-n@tsurumi-u.ac.jp

Name of contact person

1st name	Takatoshi
Middle name
Last name	Murata

Organization

Tsurumi University

Division name

School of Dental Medicine

Zip code

230-8501

Address

2-1-3 Tsurumi Yokohama

TEL

0455808462

Homepage URL

Email

murata-ta@tsurumi-u.ac.jp

Institute

Tsurumi University School of Dental Medicine, Department of Translational Research

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science (JSPS)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of Tsurumi University School of Dental Medicine

Address

2-1-3 Tsurumi Yokohama

Tel

0455808318

Email

kyoken@tsurumi-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

11

Month

30

Day

URL releasing protocol

https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f7.cgi

Publication of results

Unpublished

URL related to results and publications

https://center6.umin.ac.jp/cgi-bin/ctr/ctr_up_reg_f7.cgi

Number of participants that the trial has enrolled

8

Results

At the phylum level, Firmicutes was most abundant after advanced oral self-care in all subjects, although Proteobacteria was most abundant before self-care in four of the seven subjects. Statistical differences in alpha-diversity indices were not found , whereas beta-diversity differed significantly between the baseline and endpoint.

Results date posted

2024

Year

07

Month

24

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Japanese dentists lived in Japan, age range of 24-65 years.

Participant flow

Remaining stored saliva from previous intervention study participation was used.

Adverse events

None.

Outcome measures

Salivary microbial diversity and microbial composition.

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2020

Year

11

Month

16

Day

Date of IRB

2020

Year

11

Month

16

Day

Anticipated trial start date

2020

Year

11

Month

17

Day

Last follow-up date

2021

Year

01

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Saliva samples from previous studies (June 2014-October 2014) will be used. Therefore, no new intervention will be carried out.
All subjects were collaborators and agreed to store their saliva samples for future use.
This study plan using stored saliva was approved by the IRB.

Registered date

2020

Year

11

Month

28

Day

Last modified on

2024

Year

07

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047965

Single case data URL

Value
https://center6.umin.ac.jp/ice/47965