UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056469 |
|---|---|
| Receipt number | R000062892 |
| Scientific Title | Develpoment of xerostomia treatment targeting minor salivary glands -Occlusal stimulation and minor gland sarivary secretion- |
| Date of disclosure of the study information | 2024/12/16 |
| Last modified on | 2024/12/17 20:29:45 |
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Basic information
Public title
Develpoment of xerostomia treatment targeting minor salivary glands -Occlusal stimulation and minor gland sarivary secretion-
Acronym
Occlusal stimulation and minor gland sarivary secretion
Scientific Title
Develpoment of xerostomia treatment targeting minor salivary glands -Occlusal stimulation and minor gland sarivary secretion-
Scientific Title:Acronym
Occlusal stimulation and minor gland sarivary secretion
Region
| Japan |
Condition
Condition
Xerostomia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to obtain basic knowledge for development of xerostomia treatment, examine the existence and details of the "mastication- minor glands salivary reflex" caused by occulasal stimulation on the minor salivary glands in healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Minor salivary glands secretion
Key secondary outcomes
Bite force, Whole salivary flow rate
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Pseudo-randomization
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Bite the splint disk with a thickness of about 1mm with upper and lower teeth.
Interventions/Control_2
Dental local infiltration anesthesia into the gingiva (Oral injection dental cartridge)
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
| 55 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults with lower and upper second incisor, canine, first premolar, second premolar, and first molar
Key exclusion criteria
Adults who are allergic to dental local anesthetics.
Adults with hypertension, arteriosclerosis, heart failure, hyperthyroidism, and diabetes.
Adults who are unable to make self-judgments due to dementia, etc.
Adults who are pregnant, breastfeeding, or wish to become pregnant during the research period.
Others who are judged be a dentist to be inappropriate for study participation.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | Shizuko |
| Middle name | |
| Last name | Satoh |
Organization
Tohoku University Hospital
Division name
Division of Comprehensive Dentistry
Zip code
980-8575
Address
4-1 Seiryo-machi Aoba-ku Sendai
TEL
022-717-8434
shizuko.sato.e7@tohoku.ac.jp
Public contact
Name of contact person
| 1st name | Masahiro |
| Middle name | |
| Last name | Iikubo |
Organization
Tohoku University
Division name
Division of Dental Informatic Radiology
Zip code
980-8575
Address
4-1 Seiryo-machi Aoba-ku Sendai
TEL
022-717-8930
Homepage URL
masahiro.iikubo.c6@tohoku.ac.jp
Sponsor or person
Institute
Tohoku University
Institute
Department
Personal name
Funding Source
Organization
Tohoku University
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
Ethics Committee Tohoku University Graduate School of Dentistry
Address
4-1, Seiryo-machi, Aoba-ku, Sendai, 980-8575, Japan
Tel
022-717-8244
den-syom@grp.tohoku.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
| 2024 | Year | 12 | Month | 16 | 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
| 2024 | Year | 11 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 12 | Month | 24 | Day |
Last follow-up date
| 2029 | 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
| 2024 | Year | 12 | Month | 16 | Day |
Last modified on
| 2024 | Year | 12 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062892
