UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000037338
Receipt No. R000042564
Scientific Title Examination of the effect of gum chewing training on a questionnaire survey and saliva profiles
Date of disclosure of the study information 2019/07/31
Last modified on 2019/07/22 (Ver. 12)

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Basic information
Public title Examination of the effect of gum chewing training on a questionnaire survey and saliva profiles
Acronym Examination of the effect by gum chewing training
Scientific Title Examination of the effect of gum chewing training on a questionnaire survey and saliva profiles
Scientific Title:Acronym Examination of the effect by gum chewing training
Region
Japan

Condition
Condition None
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The effects of masseteric training by chewing gum are examined by stress questionnaire survey, oral health condition, saliva property analysis, skin condition etc.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Questionnaire of subjective evaluation
1) Stress (HAD scale)
2) Stress (short BJSQ)
Key secondary outcomes Saliva test
1) Secretion volume
2) pH
3) Buffering ability
4) Stress indicator substances (cortisol, alpha-amylase, S-IgA, Substance P)

Bad breath (total amount of sulfide in breath)

Skin examination
1) Number and size of skin texture, wrinkles and pores
2) Moisture content and elasticity of skin

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 Central registration

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Food Behavior,custom
Interventions/Control_1 Intervention : 4times daily for 6 weeks chewing 2 tablets of xylitol gum (lime mint taste: 1.5 g / piece) 10min
Interventions/Control_2 Control : Do not chew gum
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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Among the employees of Isetan Mitsukoshi Ltd. those who gave written consent after fully understanding the purpose and content of this study
Key exclusion criteria 1) Under medication
2) Regularly consume medicines, food for specified health use, health food, etc. that may affect the test results
3) Patient or had a history of serious diseases such as heart, liver, kidney, digestive system etc.
4) Pregnant (including those who may be) , who wish pregnant during the study period or who are lactating
5) Heavy drinkers
6) Have irregular diets, irregular shift rhythms, shift workers, late-night workers, etc.
7) Allergic to medicines and food
8) Skin allergy such as atopy
9) Smoke more than 21 per day on average
10) Participating in clinical trials of other medicines or health food, within 4 weeks after the trial, or who are planning to participate in other clinical trials after consenting to participate in this trial
11) Have performed special facial care (facial face, esthetic, peeling, laser treatment, etc.)
12) Trial investigator judged as inappropriate to participate in this study
Target sample size 450

Research contact person
Name of lead principal investigator
1st name Ichiro
Middle name
Last name Saito
Organization Tsurumi University School of Dental Medicine
Division name Department of Pathology
Zip code 230-8501
Address 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL 045-580-8360
Email saito-i@tsurumi-u.ac.jp

Public contact
Name of contact person
1st name Mie
Middle name
Last name Kaneko
Organization Tsurumi University School of Dental Medicine
Division name Department of Pathology
Zip code 230-8501
Address 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, Japan
TEL 045-580-8362
Homepage URL
Email kaneko-m@tsurumi-u.ac.jp

Sponsor
Institute Tsurumi University
Institute
Department

Funding Source
Organization LOTTE Co.,Ltd.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Isetan Mitsukoshi Holdings Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization The ethics committees of Tsurumi University
Address 2-1-3 Tsurumi, Tsurumi-ku, Yokohama, Kanagawa, Japan
Tel 045-581-1001
Email rinrishinsa@tsurumi-u.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 株式会社三越伊勢丹ホールディングス(東京都) / Isetan Mitsukoshi Holdings Ltd. (Tokyo)
鶴見大学（神奈川県）/ Tsurumi University (Kanagawa)

Other administrative information
Date of disclosure of the study information
2019 Year 07 Month 31 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications Submitting
Number of participants that the trial has enrolled 436
Results 
After six weeks of masticating gum on a regular basis,
 the chewing gum group had significantly lower scores
 for "depression"  items in the Hospital Anxiety and
 Depression Scale (HADS) compared with the control
 group.
Results date posted
2019 Year 07 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics 
Analysis: 346

Chewing gum group : 169
Male 78 (46.2%), Female 91 (53.8%)
Mean age 38.4 plus-minus 11.3
Age group
19 or younger : 1 (0.6%)
20-29 : 46 (27.2%)
30-39 : 40 (23.7%)
40-49 : 44 (26.0%)
50-59 : 38 (22.5%)
60 or older : 0 (0.0%)

Control group : 177
Male 80 (45.2%), Female 97 (54.8%)
Mean age 40.1 plus-minus 11.5
Age group
19 or younger : 1 (0.6%)
20-29 : 43 (24.3%)
30-39 : 43 (24.3%)
40-49 : 41 (23.2%)
50-59 : 47 (26.65%)
60 or older : 2 (1.1%)
Participant flow 
Enrollment: 436

Allocation (randomized)
Chewing gum group: 221
Control group: 215

Exclusion
Chewing gum group: 52
Control group: 38

Analysis
Chewing gum group: 169
Control group: 177
Adverse events 
None
Outcome measures 
HADS score (depression)
Chewing gum group: Before intervention 4.46 plus-minus 3.02, After intervention 3.82 plus-minus 3.02
Control group: Before intervention 4.44 plus-minus 3.15, After intervention 4.44 plus-minus 3.35
p value (mixed model ANOVA) 0.014
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2015 Year 08 Month 01 Day
Date of IRB
2015 Year 08 Month 15 Day
Anticipated trial start date
2015 Year 09 Month 01 Day
Last follow-up date
2016 Year 02 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 07 Month 11 Day
Last modified on
2019 Year 07 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042564