UMIN-CTR Clinical Trial

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
Email	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
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)

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040437