UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049036 |
|---|---|
| Receipt number | R000055501 |
| Scientific Title | Secondary stress reduction effect in using a rubber dam |
| Date of disclosure of the study information | 2022/10/01 |
| Last modified on | 2022/09/27 14:27:16 |
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Basic information
Public title
Secondary stress reduction effect in using a rubber dam
Acronym
Secondary stress reduction effect in using a rubber dam
Scientific Title
Secondary stress reduction effect in using a rubber dam
Scientific Title:Acronym
Secondary stress reduction effect in using a rubber dam
Region
| Japan |
Condition
Condition
dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In response to the CQ, "Does the use of the rubber dam moisture-proof method reduce patient stress?" The purpose is to confirm the distribution of the data for the RQ "" and to obtain summary statistics.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Questionnaire results before and after treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
1st time rubber dam used, 2nd time rubber dam not used
Interventions/Control_2
1st time rubber dam used, 2nd time rubber dam not used
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who visit Nagasaki University and undergo filling a cavity or preparation for inlay cavity under the usual method.
Patients over 18 years old
Key exclusion criteria
Patients who cannot answer the questionnaire by themselves
Patients with contraindications to use Epilide as a local anesthetic (severe hypertension, hyperthyroidism)
Patients with serious respiratory disease
Patients who are judged to be inappropriate as research subjects by the operator or reseach director
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Nobuaki |
| Middle name | |
| Last name | Magata |
Organization
Nagasaki University Hospital
Division name
Department of Dental anesthesiology
Zip code
8528501
Address
1-7-1 Sakamoto,NagaskiCity,Nagasaki,Japan
TEL
0958197748
magata@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Nobuaki |
| Middle name | |
| Last name | Magata |
Organization
NAGASAKI University Hospital
Division name
Department of Dental anesthesiology
Zip code
8528501
Address
1-7-1 Sakamoto,NagaskiCity,Nagasaki,Japan
TEL
0958197748
Homepage URL
magata@nagasaki-u.ac.jp
Sponsor or person
Institute
NAGASAKI University Hospital
Institute
Department
Personal name
Funding Source
Organization
self-procurement
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
Nagasaki University Hospital Clinical Reserch Ethics Commitee
Address
1-7-1Sakamoto,NagasakiCity,NAGASAKI,Japan
Tel
0958197229
magata@nagasaki-u.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
| 2022 | Year | 10 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2022 | Year | 09 | Month | 22 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 27 | Day |
Last modified on
| 2022 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055501
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
