UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Pilot Study on Improvement of the Articulatory Function with Palatal Augmentation Prosthesis and Artificial Tongue.
Title of the study (Brief title)	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	Shigehisa Kawakami
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
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	Masaaki Sato
Organization	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Division name	Department of Occlusal and Oral Functional Rehabilitation
Address	2-5-1, Shikata-cho, kita-ku, Okayama
TEL	086-235-6687
Homepage URL
Email	sato.masaaki@s.okayama-u.ac.jp

Sponsor
Institute	Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Okayama University
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 26 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000032582