UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045796 |
|---|---|
| Receipt number | R000051530 |
| Scientific Title | Secondary effects of stress reduction by using rubber dam under intravenous sedation for patients with severe dental phobia |
| Date of disclosure of the study information | 2021/10/26 |
| Last modified on | 2021/10/19 19:40:12 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Secondary effects of stress reduction by using rubber dam under intravenous sedation for patients with severe dental phobia
Acronym
Secondary effects of stress reduction by using rubber dam under intravenous sedation for patients with severe dental phobia
Scientific Title
Secondary effects of stress reduction by using rubber dam under intravenous sedation for patients with severe dental phobia
Scientific Title:Acronym
Secondary effects of stress reduction by using rubber dam under intravenous sedation for patients with severe dental phobia
Region
| Japan |
Condition
Condition
dental phobia
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate that the use of rubber dam during intravenous sedation has a stress-reducing effect on patients with dental phobia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sedation (PSI)
Key secondary outcomes
Respiratory rate
Percutaneous partial pressure of carbon dioxide (PtCO2)
LF/HF
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
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using rubber dam
Duration of intervention (30 minutes), number of interventions (1 time)
Interventions/Control_2
Without rubber dam
Duration of intervention (30 minutes), number of interventions (1 time)
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 meet all of the following criteria are included.
1) Patients who visit the department of special care dentistry,Nagasaki University Hospital and perform CR filling (class I, class II) or preparate inlays (class I , class II) in mandibular under intravenous sedation.
2) Patients who do not have physical or mental disorders other than dental phobia.
3) Behavior therapy was performed at the dental clinic, which is the primary medical institution, but it did not work, and he was referred to our department for the purpose of treatment with the drug behavior adjustment method. Patients who were judged to have a score of 60 or higher as a result of screening.
4) Patients over 18 years old
Key exclusion criteria
Patients who fall under the following are excluded.
1) Patients who are not suitable for applying electrode gel due to skin diseases, etc.
2) Patients judged by researchers to be inappropriate as research subjects
3) Patients who do not have the ability to consent, patients with physical and mental disabilities other than dental phobia
Target sample size
18
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
1-7-1Sakamoto,NagasakiCity,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
1-7-1Sakamoto,NagasakiCity,NAGASAKI,Japan
TEL
0958197748
Homepage URL
magata@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki university
Institute
Department
Personal name
Funding Source
Organization
Nagasaki university
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
Address
1-7-1Sakamoto,NagasakiCity,NAGASAKI,Japan
Tel
0958197748
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
| 2021 | Year | 10 | 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
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
| 2021 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2021 | Year | 10 | Month | 19 | Day |
Last modified on
| 2021 | Year | 10 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051530
