UMIN-CTR Clinical Trial

Basic information
Public title	Pilot Study on Improvement of the Articulatory Function with New Artificial Tongue
Acronym	Articulatory Function with New Artificial Tongue
Scientific Title	Pilot Study on Improvement of the Articulatory Function with New Artificial Tongue
Scientific Title:Acronym	Articulatory Function with New Artificial Tongue
Region	Japan

Condition
Condition	total glossectomy
Classification by specialty	Oto-rhino-laryngology Oral surgery Plastic surgery Dental medicine Adult
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	In order to simulate the oral environment of the patient who had total glossectomy, a simple mouthpiece will be temporarily inserted to suppress tongue movement. Palatal augmentation prosthesis and two types of artificial tongue will be added to this condition. Speech quality under these conditions will be evaluated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	To evaluate how much speech intelligibility of recorded voice and sound frequency improved by attached the New artificial tongue and Flat palate polished surface PAP.
Key secondary outcomes	To evaluate how much speech intelligibility of recorded voice and sound frequency improved by attached the anatomical artificial tongue.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	3
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Inhibitation of tongue movement
Interventions/Control_2	with palatal augmentation prosthesis and artificial tongue
Interventions/Control_3	Normal
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	No substantial loss of the tongue, no oral function abnormality
Key exclusion criteria	1) Having a history of articulation disorder. 2) Using a denture. 3) Those with strong vomiting reflex
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shigehisa Kawakami
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address	2-5-1, Shikata-cho, kita-ku, Okayama
TEL	086-235-6687
Email	s-kawa-10@t.okadai.jp

Public contact
Name of contact person	1st name Middle name Last name Hiroaki Nagatsuka
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Zip code
Address	2-5-1, Shikata-cho, kita-ku, Okayama
TEL	086-235-6687
Homepage URL
Email	nagatsuka.hiroaki@s.okayama-u.ac.jp

Sponsor
Institute	Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Institute
Department

Funding Source
Organization	Department of Occlusal and Oral Functional Rehabilitation, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization	Japanese

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	2018 Year 01 Month 22 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	2018 Year 01 Month 20 Day
Date of IRB
Anticipated trial start date	2018 Year 01 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 01 Month 22 Day
Last modified on	2018 Year 01 Month 22 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035314

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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