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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name