UMIN-ICDS Clinical Trial

Public title

Study on the effectiveness of oral hygiene instruction using mobile phone text message for older adults

Acronym

Study on the effectiveness of oral hygiene instruction using text message for older adults

Scientific Title

Study on the effectiveness of oral hygiene instruction using mobile phone text message for older adults

Scientific Title:Acronym

Study on the effectiveness of oral hygiene instruction using text message for older adults

Region

Japan

Condition

Periodontitis, Dental caries

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To clarify whether oral hygiene instruction using mobile phone text message is effective in improving oral hygiene status of older adults

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Turesky Modification of the Quigley-Hein Index at baseline and 4 weeks of follow-up

Key secondary outcomes

- Loe & Silness gingival index at baseline and 4 weeks of follow-up
- Oral health behaviors such as the frequency of tooth brushing and the use of interdental brush or dental floss at baseline and 4 weeks of follow-up
- Behavior changes based on the Health Action Process Approach at baseline and 4 weeks of follow-up

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Single blind -investigator(s) and assessor(s) are blinded

Control

Active

Stratification

YES

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

YES

Concealment

No need to know

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Behavior,custom

Interventions/Control_1

For the test group, the following interventions will be delivered.
I. Usual in-person oral hygiene instruction at baseline
II. Text messages for providing oral hygiene instruction will be sent to the mobile phone (a total of 12 messages will be sent every other day between baseline and 4 weeks of follow-up)

Interventions/Control_2

For the control group, only usual in-person oral hygiene instruction will be provided at baseline.

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

65

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Community-dwelling older adults aged 65 years or older

Key exclusion criteria

I. Subjects aged less than 65 years
II. Subjects who are edentulous
III. Subjects who do not have any mobile phones to receive the text messages
IV. Subjects unable to communicate due to hearing impairment or mental health issues
V. Subjects found to have cognitive impairment

Target sample size

100

Name of lead principal investigator

1st name	Takashi
Middle name
Last name	Hoshino

Organization

Graduate School of Medicine, Dentistry and Health Sciences, Niigata University

Division name

Faculty of Dentistry, Division of Preventive Dentistry

Zip code

9518514

Address

2-5274, Gakkocho-dori, Chuo-ku, Niigata city, Niigata, JAPAN

TEL

0252272858

Email

takashi-hoshino@dent.niigata-u.ac.jp

Name of contact person

1st name	Takashi
Middle name
Last name	Hoshino

Organization

Graduate School of Medicine, Dentistry and Health Sciences, Niigata University

Division name

Faculty of Dentistry, Division of Preventive Dentistry

Zip code

9518514

Address

2-5274, Gakkocho-dori, Chuo-ku, Niigata city, Niigata, JAPAN

TEL

0252272858

Homepage URL

Email

takashi-hoshino@dent.niigata-u.ac.jp

Institute

Niigata University

Institute

Department

Personal name

Organization

Japan Society for the Promotion of the Science

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 Niigata University

Address

1-754, Asahimachi-dori, Chuo-ku, Niigata city, Niigata, JAPAN

Tel

0252272625

Email

ethics@adm.niigata-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

新潟大学歯学部（新潟県）

Date of disclosure of the study information

2026

Year

06

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

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

Preinitiation

Date of protocol fixation

2025

Year

11

Month

21

Day

Date of IRB

2025

Year

11

Month

21

Day

Anticipated trial start date

2026

Year

06

Month

15

Day

Last follow-up date

2026

Year

12

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

This study consists of a pilot study and a main study. The minimum required sample size for a main study will be calculated based on the results of the pilot study.

Registered date

2026

Year

06

Month

11

Day

Last modified on

2026

Year

06

Month

11

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069925