UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044931 |
|---|---|
| Receipt number | R000051323 |
| Scientific Title | Effect of licking training for Down's syndrome patients with oral dysfunction; Randomized crossover study |
| Date of disclosure of the study information | 2021/07/21 |
| Last modified on | 2023/07/23 17:09:26 |
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Basic information
Public title
Effect of licking training for Down's syndrome patients with oral dysfunction; Randomized crossover study
Acronym
Effect of licking training for Down's syndrome patients with oral dysfunction; Randomized crossover study
Scientific Title
Effect of licking training for Down's syndrome patients with oral dysfunction; Randomized crossover study
Scientific Title:Acronym
Effect of licking training for Down's syndrome patients with oral dysfunction; Randomized crossover study
Region
| Japan |
Condition
Condition
oral dysfunction
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is based on the hypothesis that "continuous tongue muscle training increases tongue pressure in people with Down syndrome, improves pronunciation and swallowing functions, and reduces the number of bacteria in the oral cavity." To clarify the effects of licking training using the above on oral function such as tongue pressure, pronunciation function, and bacterial count in Down's syndrome patients, and to examine the effectiveness of licking training in Down's syndrome patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amount of change in tongue pressure value
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Vaccine | Device,equipment |
Interventions/Control_1
Licking training using stick candy first
Interventions/Control_2
Licking training using stick candy later
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
| 16 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1, Those who are 16 years old or older and 60 years old or younger at the time of obtaining consent
2, Those who have a tongue pressure value of 0 kPa or more (those who can perform a tongue pressure test)
3, Patients who agree not to lick other stick candy while participating in the study, not to lick candy except for the schedule decided in this study, and not to change the method of oral care at home during the study period.
4, A person who can obtain written consent from the surrogate, if possible, from the person who participated in this study.
Key exclusion criteria
The lower limit of the age at which the permanent dentition is completed and the eating and swallowing function is completed is set to 16 years, and the upper limit is set to 60 years for the purpose of collecting data on the elderly as much as possible. Although 16 years old is a minor, the permanent dentition is completed and the quotient force is considered to be different from that of adults. Since it is expected that the number of people that can be targeted in this study is small, even minors will be targeted.
(2) (3) (4): Set as necessary items for conducting this research.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Oda |
Organization
Hiroshima University Hospital
Division name
Special Care Dentistry
Zip code
734-8551
Address
1-2-3 Kasumi Minamiku Hiroshima City, Hiroshima, Japan
TEL
082-257-5788
ykado@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Oda |
Organization
Hiroshima University Hospital
Division name
Special Care Dedntistry
Zip code
734-8551
Address
1-2-3 Kasumi Minamiku Hiroshima City, Hiroshima, Japan
TEL
082-257-5788
Homepage URL
ykado@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Special Care Dedntistry, Hiroshima University Hospital
Address
1-2-3 Kasumi Minamiku Hiroshima City, Hiroshima, Japan
Tel
082-257-5788
ykado@hiroshima-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
広島大学病院（広島県）
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 07 | Month | 21 | 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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 07 | Month | 19 | Day |
Date of IRB
| 2021 | Year | 07 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 26 | 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
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 07 | Month | 21 | Day |
Last modified on
| 2023 | Year | 07 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051323
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