UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038719 |
|---|---|
| Receipt number | R000044145 |
| Scientific Title | Verification for techniques of desensitization therapy for tactile hyperesthesia |
| Date of disclosure of the study information | 2022/03/31 |
| Last modified on | 2023/06/02 20:42:09 |
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Basic information
Public title
Verification for techniques of desensitization therapy for tactile hyperesthesia
Acronym
Verification for techniques of desensitization therapy for tactile hyperesthesia
Scientific Title
Verification for techniques of desensitization therapy for tactile hyperesthesia
Scientific Title:Acronym
Verification for techniques of desensitization therapy for tactile hyperesthesia
Region
| Japan |
Condition
Condition
Severe motor and intellectual disabilities, , autism spectrum disorder, intellectual disability, etc.
Classification by specialty
| Pediatrics | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1. Appropriate classification of symptoms that have been considered to be hypersensitive hypertension
2. Verification of an effective method for removing hypersensitivity to tactile hypersensitivity in and around the oral cavity
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Subjective evaluation by palpation: Responses to contact with oral cavity and surrounding area
Amylase monitor
Brain response by fNirs
Key secondary outcomes
Amylase monitor
Brain response by fNirs
Questionnaire to parents
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Conventional desensitization therapy
Intervention period: 6 months
Interventions/Control_2
Static relaxation induction method combined with music therapy
Intervention period: 6 months
Interventions/Control_3
Touch care / How to avoid direct red bookstores in and around the oral cavity
Intervention period: 6 months
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
| 1 | years-old | <= |
Age-upper limit
| 12 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Target disease patients
Key exclusion criteria
Non-cooperating children
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Fumiyo |
| Middle name | |
| Last name | Tamura |
Organization
Japanese Society for Disability and Oral Health
Division name
Japanese Society for Disability and Oral Health
Zip code
1700003
Address
1-43-9 Komagome, Toshima-ku, Tokyo Komagome TS Building 4F
TEL
0339478891
jsdh@kokuhoken.or.jp
Public contact
Name of contact person
| 1st name | Fumiyo |
| Middle name | |
| Last name | Tamura |
Organization
The Nippon Dental University Tama Oral Rehabilitation Clinic
Division name
The Nippon Dental University Tama Oral Rehabilitation Clinic
Zip code
1840011
Address
44-19 Higashimachi, Koganei City, Tokyo
TEL
0423166211
Homepage URL
fumita@tky.ndu.ac.jp
Sponsor or person
Institute
Japanese Society for Disability and Oral Health
Institute
Department
Personal name
Funding Source
Organization
Japanese Society for Disability and Oral Health
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Nippon Dental University Oral Rehabilitation Tama Clinic
Nippon Dental University Hospital, Department of Oral Rehabilitation
Aichi Medical Center
General Incorporated Association National Severely Children Day Service Network Hirogari
Tohoku University School of Dentistry
Asahi University School of Dentistry
Okayama University Hospital Special Needs Dental Center
Department of Dentistry, Nihon University Matsudo Dental School
Showa University School of Dentistry Special Needs Oral Medicine Course, Oral Hygiene
Department of Dentistry, Oral Surgery and Orthodontics, Miyagi Children's Hospital
Inokai Medical Corporation Lifelong Medical Clinic Sapporo
National Hospital Organization Nishi Beppu Hospital
Tokyo Child Care Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Nippon Dental University Tama Oral Rehabilitation Clinic
Address
44-19 Higashimachi, Koganei City, Tokyo
Tel
0423166211
fumita@tky.ndu.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
| 2022 | Year | 03 | Month | 31 | 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
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 19 | Day |
Last follow-up date
| 2021 | 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
| 2019 | Year | 11 | Month | 29 | Day |
Last modified on
| 2023 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044145
