UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050545 |
|---|---|
| Receipt number | R000057326 |
| Scientific Title | Correlation of oral sensation and speech characteristics among patients with cleft lip and palate using new objective evaluation methods |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/03/09 14:29:00 |
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Basic information
Public title
Correlation of oral sensation and speech characteristics among patients with cleft lip and palate using new objective evaluation methods
Acronym
Correlation of oral sensation and speech characteristics among patients with cleft lip and palate using new objective evaluation methods
Scientific Title
Correlation of oral sensation and speech characteristics among patients with cleft lip and palate using new objective evaluation methods
Scientific Title:Acronym
Correlation of oral sensation and speech characteristics among patients with cleft lip and palate using new objective evaluation methods
Region
| Japan |
Condition
Condition
cleft lip and palate
Classification by specialty
| Oral surgery | Plastic surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In addition to the traditional subjective assessment methods, this study focuses on new objective assessment methods for determining the oral sensation and speech characteristics of patients with cleft lip and palate. Furthermore, the purpose of this study is to clarify the correlation between oral sensation and speech characteristics of the patients with cleft lip and palate.
Basic objectives2
Others
Basic objectives -Others
The objective evaluations of the oral sensations and speech characteristics of cleft lip and palate patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the MEG data
Key secondary outcomes
the oral tactile thresholds
the gustatory thresholds
the evaluation of speech characteristics
the nasalization rate
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 16 | years-old | <= |
Age-upper limit
| 30 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
A person who was born with cleft lip and palate, and has gone through cheiloplasty and palatoplasty
Through the assessment of MRI check sheet, a person whose result shows no risk of harm to attend the experiment
A right-handed person got through the assessment of dominant hand check seat
Key exclusion criteria
A person who has an oral mucosal disease
A person who has a severe vomiting reflection.
A person who has a nervous system disease
A person who undergoing orthodontic treatment or have not completed necessary orthodontic treatment
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Igarashi |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Craniofacial Anomalies
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8379
kaoru.igarashi.a3@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Eriya |
| Middle name | |
| Last name | Shimada |
Organization
Tohoku University Graduate School of Dentistry
Division name
Division of Craniofacial Anomalies
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
TEL
022-717-8277
Homepage URL
eriya.shimada.c8@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
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
Ethics committee of Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575
Tel
022-728-4105
ec_den@rinri.hosp.tohoku.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
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
In addition to the traditional subjective assessment methods (the oral tactile thresholds and the gustatory thresholds) and the evaluation of speech characteristics by a speech therapist, this study focuses on new objective assessment methods (measurement of nasalization rate using a Nasometer, measurement of somatosensory evoked magnetic fields (SEFs) during electrical stimulation of the lips and palate using Magnetoencephalography (MEG), and airflow visualization in the oral and pharyngeal regions using the simulators) for determining the oral sensation and speech characteristics of patients with cleft lip and palate.
Management information
Registered date
| 2023 | Year | 03 | Month | 09 | Day |
Last modified on
| 2023 | Year | 03 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057326
