UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032912 |
|---|---|
| Receipt number | R000037526 |
| Scientific Title | Evaluation of pain in the area of the maxillary oral cavity - Study by current perception threshold - |
| Date of disclosure of the study information | 2018/06/07 |
| Last modified on | 2018/06/07 18:59:04 |
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Basic information
Public title
Evaluation of pain in the area of the maxillary oral cavity - Study by current perception threshold -
Acronym
Evaluation of pain in the area of the maxillary oral cavity
Scientific Title
Evaluation of pain in the area of the maxillary oral cavity - Study by current perception threshold -
Scientific Title:Acronym
Evaluation of pain in the area of the maxillary oral cavity
Region
| Japan |
Condition
Condition
Missing teeth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate current perception threshold and pain threshold of mandibular mucosa using electrical stimulation.
Basic objectives2
Others
Basic objectives -Others
Pain after denture wearing
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Current perception threshold
Key secondary outcomes
Pain threshold
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Only healthy individuals were included in the study.
Key exclusion criteria
1. general health problems that could affect the measurement of nerve activity (e.g., trigeminal neuralgia or post herpetic neuralgia)
2. pacemaker wearers
3. It is a person with the past of the operation on mandible
4. obvious cognitive impairment; and
5. Pregnant woman
6. a lack of understanding of written or spoken Japanese
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kimoto Suguru |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Removable prosthodontics
Zip code
Address
sakaetyounishi 2-870-1, Matsudo-Shi, Tiba
TEL
047-368-6111
kimoto.suguru@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kimoto Suguru |
Organization
Nihon University School of Dentistry at Matsudo
Division name
Removable prosthodontics
Zip code
Address
sakaetyounishi 2-870-1, Matsudo-Shi, Tiba
TEL
047-368-6111
Homepage URL
kimoto.suguru@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Dentistry at Matsudo
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Dentistry at Matsudo
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
Address
Tel
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
| 2018 | Year | 06 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 10 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 10 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The targeted region to be measured were greater palatine foramen region and mental foramen region.
Management information
Registered date
| 2018 | Year | 06 | Month | 07 | Day |
Last modified on
| 2018 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037526
