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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040751
Receipt No. R000046526
Scientific Title A study on the usefulness of oral mucosal massage for patients with xerostomia-Open-label randomized controlled trial-
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/13

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Basic information
Public title A study on the usefulness of oral mucosal massage for patients with xerostomia-Open-label randomized controlled trial-
Acronym A study on the usefulness of oral mucosal massage
Scientific Title A study on the usefulness of oral mucosal massage for patients with xerostomia-Open-label randomized controlled trial-
Scientific Title:Acronym A study on the usefulness of oral mucosal massage for patients with xerostomia
Region
Japan

Condition
Condition xerostomia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To examine whether the oral mucosal massage for patients with xerostomia is more useful than the conventional extraoral massage and to examine the best massage method.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of subjective improvement of dry mouth symptoms by visual analogue scale between two groups 8 weeks after the start of the study
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Oral mucosal massage group: Oral mucosal massage is performed at home three times after each meal for 8 weeks
Interventions/Control_2 Extraoral massage group: Extraoral massage is performed at home three times after each meal for 8 weeks
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
90 years-old >
Gender Male and Female
Key inclusion criteria 1. Those who are 20 years of age or older at the time of obtaining consent
2. Those who are aware of dry mouth
3. Those who have 1 degree or more of clinical diagnostic criteria for dry mouth.
4. A person who, after receiving a sufficient explanation before participating in this research, has a sufficient understanding and obtained the informed consent of the person himself/herself.
Key exclusion criteria 1. Those who have a clear cause of dry mouth and are capable of causal treatment
2. Those who have difficulty in performing extraoral massage or oral mucosal massage due to hand movement disorder due to rheumatoid arthritis or cognitive impairment
3. Those who have stomatitis at the oral mucosal massage site
4. Person who used moisturizer in oral cavity within 2 months
5. Any other person who the research director judges to be inappropriate as a research target person
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Yutaka
Middle name
Last name Yamazaki
Organization Faculty of Dental Medicine, Hokkaido University
Division name Gerodontology
Zip code 060-8586
Address Kita13, Nishi7, Kita-ku, Sapporo
TEL 011-706-4582
Email yutaka8@den.hokudai.ac.jp

Public contact
Name of contact person
1st name Takae
Middle name
Last name Abe
Organization Faculty of Dental Medicine, Hokkaido University
Division name Gerodontology
Zip code 060-8586
Address Kita13, Nishi7, Kita-ku, Sapporo
TEL +81-(0)11-706-4582
Homepage URL
Email yutaka8@den.hokudai.ac.jp

Sponsor
Institute Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University
Institute
Department

Funding Source
Organization Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization hokkaido Universal Hospital Independent Clinical Research Review Committee
Address Kita14, Nishi5, Kita-ku, Sapporo
Tel 011-701-7636
Email crjimu@huhp.hokudai.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
2020 Year 07 Month 01 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 06 Month 12 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2023 Year 06 Month 30 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 06 Month 13 Day
Last modified on
2020 Year 06 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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