UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035488 |
|---|---|
| Receipt number | R000040437 |
| Scientific Title | The study on the oral sensations of cleft lip and cleft palate patients |
| Date of disclosure of the study information | 2019/01/09 |
| Last modified on | 2020/01/08 13:44:36 |
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Basic information
Public title
The study on the oral sensations of cleft lip and cleft palate patients
Acronym
The study on the oral sensations of cleft lip and cleft palate patients
Scientific Title
The study on the oral sensations of cleft lip and cleft palate patients
Scientific Title:Acronym
The study on the oral sensations of cleft lip and cleft palate patients
Region
| Japan |
Condition
Condition
Cleft lip and cleft palate
Classification by specialty
| Oral surgery | Plastic surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purposes of this study are to evaluate the characteristics of the lip and palate sensations of cleft lip and cleft palate patients by comparing their somatosensory evoked magnetic fields with those of the healthy subjects objectively.
Basic objectives2
Others
Basic objectives -Others
The objective evaluations of the oral sensations of cleft lip and cleft palate patients
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The MEG data
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
the electrical stimulation to the cleft lip and cleft palate patient's lip and palate (300 times per a part of the lip or palate)
Interventions/Control_2
the electrical stimulation to the healthy volunteer's lip and palate (300 times per a part of the lip or palate)
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
| 15 | years-old | <= |
Age-upper limit
| 31 | years-old | > |
Gender
Male and Female
Key inclusion criteria
- A person who was born with cleft lip and cleft 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
Target sample size
90
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
Craniofacial anomalies
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575
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
Craniofacial anomalies
Zip code
980-8575
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575
TEL
022-717-8277
Homepage URL
eriya@dent.tohoku.ac.jp
Sponsor or person
Institute
Tohoku University Graduate School of Dentistry
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
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
Research Ethics Committee in Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575
Tel
022-717-8244
den-syom@grp.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
| 2019 | Year | 01 | Month | 09 | 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
Enrolling by invitation
Date of protocol fixation
| 2019 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 01 | Month | 16 | Day |
Last follow-up date
| 2022 | Year | 12 | 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 | 01 | Month | 08 | Day |
Last modified on
| 2020 | Year | 01 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040437
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
