UMIN-CTR Clinical Trial

Basic information
Public title	Effects of training gum chewing on oral function
Acronym	Effects of training gum chewing on oral function
Scientific Title	Effects of training gum chewing on oral function
Scientific Title:Acronym	Effects of training gum chewing on oral function
Region	Japan

Condition
Condition	oral hypofunction
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the study was to perform a one-month gum or tablet intake intervention for men and women between the ages of 65 and 85, and change in height and weight, oral examination results, and oral function detailed examination results (bite force, dry mouth, To investigate the effect of training gum chewing on oral function based on tongue pressure, tongue and lip motor function), changes in masticatory behavior (test gum intake time), and subjective evaluation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Oral function detailed examination 1. Bite force quotient: Pressure sensitive sheet (Dental Prescale II /GC Corporation) 2. Xerostomia Spitting method Oral moisture: oral moisture meter (oral moisture meter Mucus /YOSHIDA Co., Ltd.) 3.Tongue pressure: Tongue pressure measuring device (JMS tongue pressure measuring device / JMS Co., Ltd.) 4. Tongue and lip movement function: automatic measuring instrument (Kenguchi Handy-kun / Company Takei Kikai Kogyo) 5. Evaluation of masticatory ability chewing ability judgment color change gum (chewing check gum / Lotte Co., Ltd.) 6. Chewing behavior Test gum intake time Self-administered questionnaire
Key secondary outcomes	height, weight

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking	YES
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food Behavior,custom
Interventions/Control_1	Intervention period: 1 month Study subjects chew and ingest 2 test gums / dose, 3 sets daily, at home Various measurements are taken once before and after the intervention, and data is collected.
Interventions/Control_2	Intervention period: 1 month The subjects of the study chew 3 tablets / time and 3 sets a day at home. Various measurements are taken once before and after the intervention, and data is collected.
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	65 years-old <=
Age-upper limit	85 years-old >
Gender	Male and Female
Key inclusion criteria	1) Those who have difficulty eating hard foods compared to half a year ago 2) Those who are independent in activities of daily living such as excretion, bathing, walking, eating, and conditioning 3) Persons with no history of systemic diseases such as cerebral infarction and orthopedic diseases 4) Those who have no problem with cognitive function 5) Those who are not currently receiving dental treatment 6) Those who have 20 or more remaining teeth 7) Those who can eat chewing gum and tablets 8) Those who do not have gelatin allergies
Key exclusion criteria	1) Exclude 1 test gum x 2 times less than 5 minutes in ascending order. 2) Exclude one test gum x 2 times for less than 5 minutes, and then exclude those with extremely long or short intake time. 3) The maximum number of excluded persons is 36.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name MANABU Middle name Last name KANAZAWA
Organization	Graduate School of Medical and Dental Sciences
Division name	Gerodontology and Oral Rehabilitation
Zip code	113-8549
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	0358034645
Email	m.kanazawa.gerd@tmd.ac.jp

Public contact
Name of contact person	1st name HARUKO Middle name Last name KATADA
Organization	Graduate School of Medical and Dental Sciences
Division name	Gerodontology and Oral Rehabilitation
Zip code	113-8549
Address	1-5-45 Yushima Bunkyo-ku Tokyo
TEL	03358035585
Homepage URL
Email	h.katada.gerd@tmd.ac.jp

Sponsor
Institute	TOKYO MEDICAL AND DENTAL UNIVERSITY
Institute
Department

Funding Source
Organization	LOTTE CO., LTD.
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	TOKYO MEDICAL AND DENTAL UNIVERSITY
Address	1-5-45 Yushima Bunkyo-ku Tokyo
Tel	0358035585
Email	m.kanazawa.gerd@tmd.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	東京医科歯科大学（東京都）

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 16 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	Preinitiation
Date of protocol fixation	2020 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 04 Month 01 Day
Last follow-up date	2022 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2020 Year 11 Month 16 Day
Last modified on	2020 Year 11 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048128