UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049654 |
|---|---|
| Receipt number | R000055459 |
| Scientific Title | Clinical research of the relation between burning mouth syndrome and muscle weakness of tongue. |
| Date of disclosure of the study information | 2023/01/01 |
| Last modified on | 2024/12/08 13:05:16 |
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Basic information
Public title
Clinical research of the relation between burning mouth syndrome and muscle weakness of tongue.
Acronym
burning mouth syndrome and muscle weakness of tongue
Scientific Title
Clinical research of the relation between burning mouth syndrome and muscle weakness of tongue.
Scientific Title:Acronym
burning mouth syndrome and muscle weakness of tongue
Region
| Japan |
Condition
Condition
burning mouth syndrome
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate whether muscle weakness of tongue induce and develop for burning mouth syndrome.
Basic objectives2
Others
Basic objectives -Others
Elucidate a factor to cause the plastic change in the brain in burning mouth syndrome.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of the symptom of burning mouth syndrome
Key secondary outcomes
measuring value of muscle strength of tongue
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom | Other |
Interventions/Control_1
Myofunctional therapy
Interventions/Control_2
No treatment
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
Patients with Burning Mouth Syndrome (an tongue burning sensation for which no medical or dental cause can be found except the eating)
Key exclusion criteria
every kind of stomatitis, anemia, xerostomia, oral candidiasis
Target sample size
56
Research contact person
Name of lead principal investigator
| 1st name | Kazumichi |
| Middle name | |
| Last name | Sato |
Organization
School of Medicine, International University of Health and Welfare
Division name
Department of Oral Rehabilitation and Maxillofacial Surgery
Zip code
286-8520
Address
852, hatakeda, Narita, Chiba
TEL
0476-35-5600
kazumichi312@gmail.com
Public contact
Name of contact person
| 1st name | Kazumichi |
| Middle name | |
| Last name | Sato |
Organization
School of Medicine, International University of Health and Welfare
Division name
Department of Oral Rehabilitation and Maxillofacial Surgery
Zip code
286-8520
Address
852, hatakeda, Narita, Chiba
TEL
0476-35-5600
Homepage URL
kazumichi312@gmail.com
Sponsor or person
Institute
Department of Oral Rehabilitation and Maxillofacial Surgery, School of Medicine, International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
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
International University of Health and Welfare, Narita hospital
Address
852, hatakeda, Narita, Chiba
Tel
0476-35-5600
kazumichi312@gmail.com
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
国際医療福祉大学成田病院
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 01 | 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
5
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
| 2022 | Year | 09 | Month | 30 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2026 | 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
| 2022 | Year | 11 | Month | 30 | Day |
Last modified on
| 2024 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055459
