UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000033543
Receipt number R000038249
Scientific Title Intervention study of improving oral function and reducing soiling
Date of disclosure of the study information 2018/07/29
Last modified on 2023/08/01 11:35:25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Intervention study of improving oral function and reducing soiling

Acronym

improving oral function and soiling

Scientific Title

Intervention study of improving oral function and reducing soiling

Scientific Title:Acronym

improving oral function and soiling

Region

Asia(except Japan)


Condition

Condition

Subject with natural dentition or dentition with missing teeth

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Consider whether strengthening of oral function such as tongue pressure and oral dia doko kinesis will reduce contamination in the oral cavity.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Soiling of oral cavity, tongue pressure and Oral dia doko kinesis for measuring contamination of the lip and tongue.

Key secondary outcomes

Oral wetness


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Cluster

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Maneuver

Interventions/Control_1

Instruct them to perform "Kappo chan's exercise gymnastics" every day after getting up or before going to bed

Interventions/Control_2

Without the oral function training method "Kappo-chan's Ken gymnastics"

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

110 years-old >

Gender

Male and Female

Key inclusion criteria

Faculty and staff of our university, students, and edentulous chin. A visiting patient regularly undergoing maintenance at our hospital or Higashima dental office. The present study examines improvements of oral function and reduction of soil in the oral cavity, and it is considered that the state in the oral cavity greatly affects the results. Therefore, it is necessary to set a group of dentition and jaws not performing prosthetic treatment such as dental teeth and clothes, a group of deficient dentition left without leaving a tooth, but a prosthetic treatment enforcement group performing prosthodontic treatment I think that it is necessary.

Key exclusion criteria

Those who can not express their will, Those who can not communicate, Person who did not obtain consent, Patient wearing a pacemaker

Target sample size

300


Research contact person

Name of lead principal investigator

1st name Tetsuo
Middle name
Last name Ichikawa

Organization

Tokushima University Graduate School of Biomedical Sciences

Division name

Department of Prosthodontics and Oral Rehabilitation

Zip code

770-8504

Address

3-18-15 Kuramoto, Tokushima, Japan

TEL

088-633-7347

Email

ichi@tokushima-u.ac.jp


Public contact

Name of contact person

1st name Takaharu
Middle name
Last name Goto

Organization

Tokushima University Graduate School of Biomedical Sciences

Division name

Department of Prosthodontics and Oral Rehabilitation

Zip code

770-8504

Address

3-18-15 Kuramoto, Tokushima, Japan

TEL

088-633-7347

Homepage URL


Email

tak510@tokushima-u.ac.jp


Sponsor or person

Institute

Tokushima University Graduate School of Biomedical Sciences, Department of Prosthodontics and Oral Rehabilitation

Institute

Department

Personal name



Funding Source

Organization

No

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics Committee of Tokushima University Hospital

Address

3-18-15, Kuramoto, Tokushima

Tel

0886339294

Email

first-ec@tokushima-u.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

2018 Year 07 Month 29 Day


Related information

URL releasing protocol

https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000033543

Publication of results

Unpublished


Result

URL related to results and publications

https://rctportal.niph.go.jp/s/detail/um?trial_id=UMIN000033543

Number of participants that the trial has enrolled

0

Results

before recruitment

Results date posted

2023 Year 08 Month 01 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Persons with edentulous jaws and those with missing dentition

Participant flow

Parallel group comparison

Adverse events

Aggravation of primary disease, aggravation of complications, complications

Outcome measures

Soiling of oral cavity, tongue pressure and Oral dia doko kinesis for measuring contamination of the lip and tongue.

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Open public recruiting

Date of protocol fixation

2018 Year 07 Month 08 Day

Date of IRB

2018 Year 08 Month 27 Day

Anticipated trial start date

2018 Year 08 Month 27 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

Other related information



Management information

Registered date

2018 Year 07 Month 27 Day

Last modified on

2023 Year 08 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038249


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name