UMIN-CTR Clinical Trial

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
Email	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
Email	eriya@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047275