UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037338 |
|---|---|
| Receipt number | 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 12:21:14 |
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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
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
kaneko-m@tsurumi-u.ac.jp
Sponsor or person
Institute
Tsurumi University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042564
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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