UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000051187
Receipt number R000058366
Scientific Title Survey of attitudes toward periodontal disease prevention using a novel periodontal disease examination method
Date of disclosure of the study information 2023/05/31
Last modified on 2024/06/06 11:03:17

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Basic information

Public title

Survey of attitudes toward periodontal disease prevention using a novel periodontal disease examination method

Acronym

Survey of attitudes toward periodontal disease prevention using a novel periodontal disease examination method

Scientific Title

Survey of attitudes toward periodontal disease prevention using a novel periodontal disease examination method

Scientific Title:Acronym

Survey of attitudes toward periodontal disease prevention using a novel periodontal disease examination method

Region

Japan


Condition

Condition

periodontal disease

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To evaluate whether the newly developed periodontal disease examination method and lectures on periodontal disease will change knowledge of periodontal disease and oral health behaviors among adults who are not required to undergo periodontal disease examinations.

Basic objectives2

Others

Basic objectives -Others

Patient behavior change

Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Oral health behavior change (improvement)

Key secondary outcomes

Receive a full examination at a dental office
Understanding of periodontal disease


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Educational,Counseling,Training

Type of intervention

Behavior,custom

Interventions/Control_1

After attending a course on periodontal disease, a new periodontal disease examination method will be administered to assess understanding of periodontal disease and behavioral changes in oral health.

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



Eligibility

Age-lower limit

18 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

Employees of companies in Fukuoka Prefecture
Employees who have given consent to participate in the study

Key exclusion criteria

Persons who cannot give consent to participate in the research
Person with no teeth
Those taking antibacterial or anti-inflammatory drugs within the past month
Other persons deemed by the physician in charge to be inappropriate to participate

Target sample size

200


Research contact person

Name of lead principal investigator

1st name Tatsuji
Middle name
Last name Nishihara

Organization

Kyushu Dental University

Division name

Faculty of Dentistry

Zip code

8038580

Address

2-6-1 Manazuru, Kokurakita-ku,Kitakyushu

TEL

093-582-1131

Email

tatsujin@kyu-dent.ac.jp


Public contact

Name of contact person

1st name Maki
Middle name
Last name Inoue

Organization

Kyushu Dental University

Division name

Dental Center for Regional Medical Survey

Zip code

8038580

Address

2-6-1 Manazuru, Kokurakita-ku,Kitakyushu

TEL

093-582-1131

Homepage URL


Email

r20inoue@fa.kyu-dent.ac.jp


Sponsor or person

Institute

Kyushu Dental University

Institute

Department

Personal name



Funding Source

Organization

None

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Kyushu Dental University Educational Affairs section

Address

2-6-1 Manazuru, Kokurakita-ku,Kitakyushu

Tel

093-285-3012

Email

kyoumu@kyu-dent.ac.jp


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2023 Year 05 Month 31 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

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



Progress

Recruitment status

Terminated

Date of protocol fixation

2022 Year 10 Month 04 Day

Date of IRB

2022 Year 10 Month 04 Day

Anticipated trial start date

2022 Year 10 Month 04 Day

Last follow-up date

2025 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2023 Year 05 Month 29 Day

Last modified on

2024 Year 06 Month 06 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058366