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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000030923
Receipt No. R000035314
Scientific Title Pilot Study on Improvement of the Articulatory Function with New Artificial Tongue
Date of disclosure of the study information 2018/01/22
Last modified on 2018/01/22

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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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