UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029674 |
|---|---|
| Receipt number | R000033811 |
| Scientific Title | Elucidation of mental stress mechanism during dental treatment and examination of relaxation method applying hug effect. -Open labeled randomized comparison test- |
| Date of disclosure of the study information | 2017/10/24 |
| Last modified on | 2017/10/24 18:36:26 |
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Basic information
Public title
Elucidation of mental stress mechanism during dental treatment and examination of relaxation method applying hug effect. -Open labeled randomized comparison test-
Acronym
Elucidation of mental stress mechanism during dental treatment and examination of relaxation method applying hug effect. -Open labeled randomized comparison test-
Scientific Title
Elucidation of mental stress mechanism during dental treatment and examination of relaxation method applying hug effect. -Open labeled randomized comparison test-
Scientific Title:Acronym
Elucidation of mental stress mechanism during dental treatment and examination of relaxation method applying hug effect. -Open labeled randomized comparison test-
Region
| Japan |
Condition
Condition
partially edentulous arch
Classification by specialty
| Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1.Consider the stress a patient receives in impression taking prosses.
2.Inspect the stress relaxation effect by "the hug" .
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
L/H average value of precise impression taking
Key secondary outcomes
1.DAS value
2.VAS value
3.Modified DFS value
4.L/H average value of preliminary impression taking
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Hugvie group ; hold a "hugvie" during precise impression taking.
Interventions/Control_2
non-Hugvie group ; not hold a "hugvie" during precise impression taking.
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
1.Over 20 years old patients when this study agreement is obtained.
2.Patients planning to take precise impression after border molding.
Key exclusion criteria
1.Immediate denture patients
2.Arrhythmic patients
3.Panic disorder patients
4.Psychiatric disorder patients
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Marie Goto |
Organization
Hokkaido University Hospital
Division name
Department of Removable Prosthdontics
Zip code
Address
NIshi-5, Kita-14, KIta-ku,Sapporo,Japan
TEL
+81-11-706-4270
marie@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Marie Goto |
Organization
Hokkaido University Hospital
Division name
Department of Removable Prosthdontics
Zip code
Address
NIshi-5, Kita-14, KIta-ku,Sapporo,Japan
TEL
+81-11-706-4270
Homepage URL
marie@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotin of science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2017 | Year | 10 | Month | 24 | 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
| 2017 | Year | 10 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 23 | Day |
Last modified on
| 2017 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033811
| 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 |
