UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000028458
Receipt number R000032582
Scientific Title Pilot Study on Improvement of the Articulatory Function with Palatal Augmentation Prosthesis and Artificial Tongue.
Date of disclosure of the study information 2017/09/30
Last modified on 2019/02/19 12:41:37

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Basic information

Public title

Pilot Study on Improvement of the Articulatory Function with Palatal Augmentation Prosthesis and Artificial Tongue.

Acronym

Study on Improvement of the Articulatory Function with Palatal Augmentation Prosthesis and Artificial Tongue.

Scientific Title

Pilot Study on Improvement of the Articulatory Function with Palatal Augmentation Prosthesis and Artificial Tongue.

Scientific Title:Acronym

Study on Improvement of the Articulatory Function with Palatal Augmentation Prosthesis and Artificial Tongue.

Region

Japan


Condition

Condition

helthy people

Classification by specialty

Oto-rhino-laryngology 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

Evaluate record voice how much speech intelligibility improved by attached the artificial tongue and Soft PAP.

Key secondary outcomes

Consider whether sound frequency improves by wearing artificial tongue.


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

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

65 years-old >

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.

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 Masaaki Sato

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

sato.masaaki@s.okayama-u.ac.jp


Sponsor or person

Institute

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University

Institute

Department

Personal name



Funding Source

Organization

Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University

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


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

2017 Year 09 Month 30 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

2017 Year 08 Month 26 Day

Date of IRB


Anticipated trial start date

2017 Year 08 Month 26 Day

Last follow-up date

2018 Year 04 Month 18 Day

Date of closure to data entry


Date trial data considered complete

2018 Year 12 Month 14 Day

Date analysis concluded

2019 Year 01 Month 08 Day


Other

Other related information



Management information

Registered date

2017 Year 07 Month 31 Day

Last modified on

2019 Year 02 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032582


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name