UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026930 |
|---|---|
| Receipt number | R000030895 |
| Scientific Title | The summary of dental treatment of our dental clinic under general anesthesia |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2022/10/15 17:53:39 |
* 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
The summary of dental treatment of our dental clinic under general anesthesia
Acronym
The summary of dental treatment of our dental clinic under general anesthesia
Scientific Title
The summary of dental treatment of our dental clinic under general anesthesia
Scientific Title:Acronym
The summary of dental treatment of our dental clinic under general anesthesia
Region
| Japan |
Condition
Condition
Patients who received dental treatment under general anesthesia in the Medical Corporation BunkouKai Special Needs Center.
Classification by specialty
| Anesthesiology | Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Investigation of the background of patients, occurrence of troubles and adverse events underwent general anesthesia, in the Special Needs Center.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Patient's age, medical history, adverse event, operation time, anesthesia time
Key secondary outcomes
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
| 1 | years-old | < |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients who received dental treatment under general anesthesia at the Special Needs Center of the Medical Corporation BunkouKai.
Key exclusion criteria
none
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hoshijima |
Organization
Special Needs Center of the Medical Corporation BunkouKai
Division name
Oral maxillo-facial surgery
Zip code
350-0495
Address
2765-5 Ujiie, Sakura-shi, Tochigi
TEL
028-682-7238
hhoshi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Hiroshi |
| Middle name | |
| Last name | Hoshijima |
Organization
Special Needs Center of the Medical Corporation BunkouKai
Division name
Oral maxillo-facial surgery
Zip code
350-0495
Address
2765-5 Ujiie, Sakura-shi, Tochigi
TEL
028-682-7238
Homepage URL
hhoshi@saitama-med.ac.jp
Sponsor or person
Institute
Special Needs Center of the Medical Corporation BunkouKai
Institute
Department
Personal name
Funding Source
Organization
Special Needs Center of the Medical Corporation BunkouKai
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
Special Needs Center of the Medical Corporation BunkouKai
Address
2765-5 Ujiie, Sakura-shi, Tochigi
Tel
028-682-7238
hhoshi@saitama-med.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
| 2017 | Year | 06 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2017 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2017 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
We investigate that patients who received dental treatment under general anesthesia at the Special Needs Center of the Medical Corporation BunkouKai.
Data extract from patient records, anesthesia records (patient age, past history, adverse events, operation time, anesthesia time).
Management information
Registered date
| 2017 | Year | 04 | Month | 10 | Day |
Last modified on
| 2022 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030895
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
