UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035488
Receipt No. R000040437
Official scientific title of the study 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 2019/01/08

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Official scientific title of the study The study on the oral sensations of cleft lip and cleft palate patients
Title of the study (Brief title) 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 Kaoru Igarashi
Organization Tohoku University Graduate School of Dentistry
Division name Division of Oral Dysfunction Science
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575
TEL 022-717-8379
Email kaoru.igarashi.a3@tohoku.ac.jp

Public contact
Name of contact person Eriya Shimada
Organization Tohoku University Graduate School of Dentistry
Division name Division of Oral Dysfunction Science
Address 4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575
TEL 022-717-8277
Homepage URL
Email eriya@dent.tohoku.ac.jp

Sponsor
Institute Tohoku University Graduate School of Dentistry
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2019 Year 01 Month 08 Day
Anticipated trial start date
2019 Year 01 Month 16 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2019 Year 01 Month 08 Day
Last modified on
2019 Year 01 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040437

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.