UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057417 |
|---|---|
| Receipt number | R000065603 |
| Scientific Title | Clarifying the effects of headache and salivary gland massage on saliva |
| Date of disclosure of the study information | 2025/03/26 |
| Last modified on | 2025/03/26 19:51:03 |
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Basic information
Public title
Clarifying the effects of headache and salivary gland massage on saliva
Acronym
Effects of headache and salivary gland massage on saliva
Scientific Title
Clarifying the effects of headache and salivary gland massage on saliva
Scientific Title:Acronym
Effects of headache and salivary gland massage on saliva
Region
| Japan |
Condition
Condition
Decreased saliva associated with headaches
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of saliva volume and salivary gland massage in adult women with headaches.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Flow rate of saliva
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
No headache No salivary gland massage
Interventions/Control_2
No headache, salivary gland massage
Interventions/Control_3
Headache, No salivary gland massage
Interventions/Control_4
Headache and salivary gland massage
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
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Students and staff of the Department of Dental Hygiene, Kanagawa Dental University, Junior College.
Key exclusion criteria
Those with secondary headaches
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kanagawa Dental University
Division name
Junior College
Zip code
238-8580
Address
82 Inaoka, Yokosuka, Kanagawa, Japan
TEL
0468228755
yuko@yd6.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Yamamoto |
Organization
Kanagawa Dental University
Division name
Junior College
Zip code
238-8580
Address
82 Inaoka, Yokosuka, Kanagawa, Japan
TEL
0468228755
Homepage URL
yuko@yd6.so-net.ne.jp
Sponsor or person
Institute
Kanagawa Dental University, Junior College
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental University, Junior College
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
Kanagawa Dental University
Address
82 Inaoka, Yokosuka, Kanagawa, Japan
Tel
0468228826
kenkyo@kdu.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
神奈川歯科大学短期大学部（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 26 | 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
40
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
No longer recruiting
Date of protocol fixation
| 2024 | Year | 07 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 07 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2026 | 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
| 2025 | Year | 03 | Month | 26 | Day |
Last modified on
| 2025 | Year | 03 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065603
