UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046446 |
|---|---|
| Receipt number | R000052994 |
| Scientific Title | Development of an oral health support program for intellectually disabled persons |
| Date of disclosure of the study information | 2021/12/22 |
| Last modified on | 2025/02/03 10:49:35 |
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Basic information
Public title
Development of an oral health support program for intellectually disabled persons
Acronym
Development of an oral health support program for intellectually disabled persons
Scientific Title
Development of an oral health support program for intellectually disabled persons
Scientific Title:Acronym
Development of an oral health support program for intellectually disabled persons
Region
| Japan |
Condition
Condition
Oral Hygiene condition of persons with intellectual disabilities
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To develop and examine the effects of an oral health support program that compensates for executive function weakness in persons with intellectual disabilities.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Simplified Oral Hygiene Index, Plaque Control Record, Debris Index, Debris Index All Surfaces Method
Key secondary outcomes
Amount of tooth Blushing support
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
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
Intervention: Toothbrushing instructions that support the executive functions required for effective toothbrushing / Control: Conventional tooth brushing instructions over the same period of time
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
1. Intellectually disabled persons
2. User of commuting welfare facilities for intellectually disabled persons
Key exclusion criteria
1. Disabled persons without intellectual disability
2. Intellectually disabled parsons with functional impairment in the upper limb
3. Intellectually disabled persons who receive dental checkups visited the dental clinic last month
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Satoko |
| Middle name | |
| Last name | Shibata |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Oral Science for Health Promotion
Zip code
951-8514
Address
2-5274, Gakkocho-Dori, Chuo-ku, Niigata, Niigata
TEL
025-227-0681
sibata@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Satoko |
| Middle name | |
| Last name | Shibata |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Oral Science for Health Promotion
Zip code
951-8514
Address
2-5274, Gakkocho-Dori, Chuo-ku, Niigata, Niigata
TEL
025-227-0681
Homepage URL
sibata@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
2-5274, Gakkocho-Dori, Chuo-ku, Niigata, Niigata
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science, and Technology
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
The Ethics Committee of Niigata University
Address
1-757, Asahimati-dori, Chuo-ku Niigata, Niigata
Tel
025-227-2625
ethics@adm.niigata-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
| 2021 | Year | 12 | Month | 22 | 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
35
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
Suspended
Date of protocol fixation
| 2020 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 09 | Month | 10 | 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
| 2021 | Year | 12 | Month | 22 | Day |
Last modified on
| 2025 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052994
