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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||||
Condition | total glossectomy | |||||
Classification by specialty |
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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 |
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Interventions/Control_1 | Inhibitation of tongue movement | |
Interventions/Control_2 | with palatal augmentation
prosthesis and artificial tongue |
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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 |
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Age-upper limit |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 | ||||||
s-kawa-10@t.okadai.jp |
Public contact | |||||||
Name of contact person |
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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 | |||||||
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 | |
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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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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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 |