UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000030923
Receipt number 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 2022/01/17 10:13:47

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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 or person

Institute

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

Institute

Department

Personal name



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

Completed

Date of protocol fixation

2018 Year 01 Month 20 Day

Date of IRB

2018 Year 01 Month 20 Day

Anticipated trial start date

2018 Year 01 Month 20 Day

Last follow-up date

2020 Year 03 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

2018 Year 01 Month 22 Day

Last modified on

2022 Year 01 Month 17 Day



Link to view the page

Value
https://center6.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