UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029157 |
|---|---|
| Receipt number | 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 | 2024/03/21 21:48:29 |
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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
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
n4160@osaka-med.ac.jp
Sponsor or person
Institute
Department of Oral Surgery, Osaka Medical College
Institute
Department
Personal name
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
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
https://www.ompu.ac.jp/research/omc/outcome/seeds/f2pjgc000000fja4.html
Publication of results
Unpublished
Result
URL related to results and publications
https://www.ompu.ac.jp/research/omc/outcome/seeds/f2pjgc000000fja4.html
Number of participants that the trial has enrolled
16
Results
Patients who had undergone mandibular reconstruction and had no mastication or swallowing problems were included in the study. The subjects were asked to chew and their chewing efficiency was measured. The patients swallowed the chewed gummy jelly, and the state immediately before swallowing the gummy jelly and the swallowing movement were simultaneously observed using a transnasal optical endoscope to observe the swallowing function.
Results date posted
| 2023 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who had undergone mandibular reconstruction after a diagnosis of mandibular malignancy at our hospital and had no difficulty in chewing or swallowing were included in the study. Patients who were able to make contact with the patient were included in the study, and those who were unable to take oral intake were not included in the study.
Participant flow
Patients who were able to take oral intake after mandibular reconstruction were offered and consented to functional measurements to measure postoperative eating and swallowing function and were studied. Participants were measured in the outpatient clinic of the Department of Dental Surgery and the Department of Otolaryngology/Head and Neck Surgery.
Adverse events
Nothing of note
Outcome measures
Masticatory efficiency, swallowing motion, occlusal force, tongue pressure, and lip closure ability. Functional measurements revealed a relationship between masticatory efficiency and swallowing movements.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033331
