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 | 2025/01/30 09:24:57 |
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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 | 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
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
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
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
| 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
| 2018 | Year | 07 | Month | 27 | Day |
Last modified on
| 2025 | Year | 01 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038249
