UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056224 |
|---|---|
| Receipt number | R000064237 |
| Scientific Title | A Study on the Effect of Mouth Rinsing Training on the Improvement of Oral Function |
| Date of disclosure of the study information | 2024/12/01 |
| Last modified on | 2025/05/23 11:48:49 |
* 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
A Study on the Effect of Mouth Rinsing Training on the Improvement of Oral Function
Acronym
A Study on the Effect of Mouth Rinsing Training on the Improvement of Oral Function
Scientific Title
A Study on the Effect of Mouth Rinsing Training on the Improvement of Oral Function
Scientific Title:Acronym
A Study on the Effect of Mouth Rinsing Training on the Improvement of Oral Function
Region
| Japan |
Condition
Condition
oral hypofunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effectiveness of Mouth Rinsing training in improving oral function
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Lip Closure Force Three Months After Intervention
Key secondary outcomes
Oral Functional Status and Periodontal Condition Three Months After Intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
The subjects will perform instructed mouth rinsing training at home once daily for three months, using 30 ml of water.
Interventions/Control_2
The subjects will perform unguided mouth rinsing at home once daily for three months, using 30 ml of water.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients undergoing periodontal maintenance or supportive periodontal therapy (SPT)
Key exclusion criteria
Individuals diagnosed with oral hypofunction.
Those experiencing difficulty with mouth rinsing.
Patients with dementia.
Individuals with a history of radiation therapy in the maxillofacial region.
Those already performing oral functional training.
Individuals who underwent dental treatment (including the creation or repair of dentures or temporary crowns) after the first examination.
Individuals unable to provide informed consent.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Shino |
| Middle name | |
| Last name | Maeda |
Organization
Kyusyu Dental University
Division name
School of oral Health Sciences
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3101
r21yamaguchi4@fa.kyu-dent.ac.jp
Public contact
Name of contact person
| 1st name | Shino |
| Middle name | |
| Last name | Maeda |
Organization
Kyusyu Dental University
Division name
School of oral Health Sciences
Zip code
803-8580
Address
2-6-1, Manazuru, Kitakyushu, Fukuoka
TEL
093-285-3101
Homepage URL
r21yamaguchi4@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
Ethics Review Committee, Kyushu Dental University
Address
2-6-1, Manazuru, Kitakyushu, Japan
Tel
093-285-3011
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
| 2024 | Year | 12 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2024 | Year | 11 | Month | 08 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 11 | Month | 21 | Day |
Last modified on
| 2025 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000064237
