UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051080 |
|---|---|
| Receipt number | R000058253 |
| Scientific Title | A multi-institutional, retrospective, observational study on the healing course of post-operative hypersensitivity during extraction of mandibular wisdom teeth. |
| Date of disclosure of the study information | 2023/06/17 |
| Last modified on | 2023/05/17 11:11:39 |
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Basic information
Public title
A multi-institutional, retrospective, observational study on the healing course of post-operative hypersensitivity during extraction of mandibular wisdom teeth.
Acronym
Study on postoperative hypersensitivity during extraction of mandibular wisdom teeth.
Scientific Title
A multi-institutional, retrospective, observational study on the healing course of post-operative hypersensitivity during extraction of mandibular wisdom teeth.
Scientific Title:Acronym
Study on postoperative hypersensitivity during extraction of mandibular wisdom teeth.
Region
| Japan |
Condition
Condition
Wisdom tooth
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To identify factors that can contribute to recovery and factors that impede recovery in the development of paresthesia following extraction of mandibular wisdom teeth.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Number of days from the date of tooth extraction to the occurrence of the event with partial or complete recovery of the event in the observation period.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients who underwent mandibular wisdom tooth extraction at the collaborating institution between 1 April 2014 and 30 June 2022 and developed postoperative hypersensitivity.
(ii) Patients who have already died as of the study start date.
Key exclusion criteria
(i) Cases where medical information records are poorly documented and insufficient information is available.
Target sample size
280
Research contact person
Name of lead principal investigator
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki university
Division name
Department of Clinical Oral Oncology
Zip code
852-8588
Address
1-7-1 Sakamoto, Nagasaki ,Japan
TEL
0958197698
naruse12@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Tomofumi |
| Middle name | |
| Last name | Naruse |
Organization
Nagasaki university
Division name
Department of Clinical Oral Oncology
Zip code
852-8588
Address
1-7-1 sakamoto, nagasaki, Japan
TEL
0958197698
Homepage URL
naruse12@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
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki university
Address
1-7-1 sakamoto, nagasaki, Japan
Tel
0958197726
naruse12@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
| 2023 | Year | 06 | Month | 17 | 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
| 2023 | Year | 05 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 06 | Month | 17 | 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
None
Management information
Registered date
| 2023 | Year | 05 | Month | 17 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058253
