UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040751 |
|---|---|
| Receipt number | 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 | 2023/06/08 17:15:16 |
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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
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
yutaka8@den.hokudai.ac.jp
Sponsor or person
Institute
Gerodontology, Department of Oral Health Science, Faculty of Dental Medicine, Hokkaido University
Institute
Department
Personal name
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
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
Open public recruiting
Date of protocol fixation
| 2020 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2020 | Year | 07 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 13 | Day |
Last modified on
| 2023 | Year | 06 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046526
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
