UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041407 |
|---|---|
| Receipt number | R000047275 |
| Scientific Title | The study on the oral sensations and oral functions of cleft lip and cleft palate patients |
| Date of disclosure of the study information | 2020/08/14 |
| Last modified on | 2020/08/13 18:54:59 |
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Basic information
Public title
The study on the oral sensations and oral functions of cleft lip and cleft palate patients
Acronym
The study on the oral sensations and oral functions of cleft lip and cleft palate patients
Scientific Title
The study on the oral sensations and oral functions of cleft lip and cleft palate patients
Scientific Title:Acronym
The study on the oral sensations and oral functions 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 assess and to analyze the characteristics of the oral senses and oral functions of cleft lip and cleft palate patients by those of the healthy subjects.
Basic objectives2
Others
Basic objectives -Others
The assessment of the oral sensations and the oral functions of cleft lip and cleft palate patients
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
assessment of tactile stimulation
Key secondary outcomes
assessment of taste stimulation
assessment of tongues and lips pressure
language assessment
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
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
the tactile stimulation to the lip and palate by the Semmes - Weinstein Monofilaments
Interventions/Control_2
the taste stimulation to the tongue and palate by the taste-disc
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
| 11 | years-old | <= |
Age-upper limit
| 25 | 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
Key exclusion criteria
A person who has at least one of the following conditions:
has an oral mucosal disease
has a severe vomiting reflection.
has a nervous system disease
has communication difficulty
Target sample size
110
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 Hospital
Division name
Department of Orthodontics and Speech Therapy for Craniofacial Anomalies
Zip code
980-8574
Address
1-1, Seiryo-machi, Aoba-ku, Sendai
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
MEXT(JAPAN)
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
Tohoku University Graduate School of Dentistry Institutional Review Board
Address
4-1, Seiryo-machi, Aoba-ku, Sendai
Tel
022-717-8244
den-syom@bureau.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
| 2020 | Year | 08 | Month | 14 | 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
| 2020 | Year | 07 | Month | 31 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 08 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 13 | Day |
Last modified on
| 2020 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047275
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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