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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000029157
Receipt No. R000033331
Scientific Title Investigation of a new evaluation method using test gummy jelly which comprehensively evaluates chewing swallowing movement after mandibular bone reconstruction
Date of disclosure of the study information 2017/09/19
Last modified on 2019/03/18

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Basic information
Public title Investigation of a new evaluation method using test gummy jelly which comprehensively evaluates chewing swallowing movement after mandibular bone reconstruction
Acronym A study on a method to evaluate chewing swallow after mandibular reconstruction by gumjelly
Scientific Title Investigation of a new evaluation method using test gummy jelly which comprehensively evaluates chewing swallowing movement after mandibular bone reconstruction
Scientific Title:Acronym A study on a method to evaluate chewing swallow after mandibular reconstruction by gumjelly
Region
Japan

Condition
Condition mandible reconstruction
Classification by specialty
Oral surgery Dental medicine
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To clarify the form (size, shape, color tone) of gummy that can perform the chewing / swallowing function test properly. It is also intended to evaluate a new evaluation method after mandibular bone reconstruction, which evaluates mastication / swallowing function as a series of exercises.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase I,II

Assessment
Primary outcomes Evaluation of chewing function: Gumi is chewed 30 times freely and spit out. Evaluate the grinding degree of gummies on the scale table. The occlusal ability is measured by using an occlusal capability measuring instrument to measure occlusal pressure.
Evaluation of swallowing function: As for evaluation, chewing swallowing evaluation is performed with reference to the Japan Feeding and Swallowing Rehabilitation Association "Revised Procedure for Swallowing Endoscopy 2012 Revised".
Specifically, gumi is chewed until swallowable, swallowed, observed by the nasopharyngeal fiber, whether there is no choking at swallowing, presence of residual gummy, smooth flow into the pharynx Evaluate points.
The observation result is made into a database, examination of the size, form and color tone suitable for evaluation of the patient after the mandibular bone reconstruction, and preparation of adjusted gummies. Using this, masticatory function evaluation and swallowing function evaluation are performed again for patients after mandibular bone reconstruction. In addition, based on the data obtained by the mastication function and the swallowing function, the functional evaluation method is considered as an integrated evaluation of chewing and swallowing function.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Evaluation of chewing function: Gumi is chewed 30 times freely and spit out. Evaluate the grinding degree of gummies on the scale table. The occlusal ability is measured by using an occlusal capability measuring instrument to measure occlusal pressure.
Evaluation of swallowing function: As for evaluation, chewing swallowing evaluation is performed with reference to the Japan Feeding and Swallowing Rehabilitation Association "Revised Procedure for Swallowing Endoscopy 2012 Revised".
Specifically, gumi is chewed until swallowable, swallowed, observed by the nasopharyngeal fiber, whether there is no choking at swallowing, presence of residual gummy, smooth flow into the pharynx Evaluate points.
The observation result is made into a database. The inspection of the county (20 people) is terminated. We examine the size, form and color tone suitable for patient evaluation after mandibular bone reconstruction, and create adjusted gummies. Using this, masticatory function evaluation and swallowing function evaluation are performed again in the target group. In addition, based on the data obtained by the mastication function and the swallowing function, the functional evaluation method is considered as an integrated evaluation of chewing and swallowing function.
Interventions/Control_2
Interventions/Control_3
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 Those who are 20 years or older who have no abnormality in feeding / swallowing in patients after mandibular bone reconstruction. Those who are 20 years old or older who have no history and no abnormality in eating or swallowing.
Key exclusion criteria Underage, those with chew swallowing disorder, and those with allergies to gummies
Target sample size 35

Research contact person
Name of lead principal investigator
1st name Ueno
Middle name
Last name Takaaki
Organization Osaka Medical College
Division name Department of Oral Surgery
Zip code 5698686
Address 2-7 Daigakumachi, Takatsuki-City, Osaka 569-8686, Japan
TEL 072-683-1221
Email n4160@osaka-med.ac.jp

Public contact
Name of contact person
1st name Nakajima
Middle name
Last name Yoichiro
Organization Osaka Medical College
Division name Department of Oral Surgery
Zip code 569-8686
Address 2-7 Daigakumachi, Takatsuki-City, Osaka 569-8686, Japan
TEL 072-683-1221
Homepage URL
Email n4160@osaka-med.ac.jp

Sponsor
Institute Department of Oral Surgery, Osaka Medical College
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
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 Department of Oral Surgery, Osaka Medical College
Address 2-7 Daigakumachi, Takatsuki-City, Osaka 569-8686, Japan
Tel 0726831221
Email n4160@osaka-med.ac.jp

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 19 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 Enrolling by invitation
Date of protocol fixation
2017 Year 07 Month 12 Day
Date of IRB
2017 Year 09 Month 19 Day
Anticipated trial start date
2017 Year 09 Month 19 Day
Last follow-up date
2020 Year 03 Month 31 Day
Date of closure to data entry
2020 Year 03 Month 31 Day
Date trial data considered complete
2020 Year 03 Month 31 Day
Date analysis concluded
2020 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 15 Day
Last modified on
2019 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033331

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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