UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059877 |
|---|---|
| Receipt number | R000068418 |
| Scientific Title | Observational Study on Body Temperature Change in Dental Patients Under Intravenous Sedation |
| Date of disclosure of the study information | 2025/12/01 |
| Last modified on | 2025/11/25 19:04:32 |
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Basic information
Public title
Profile of Temperature under Sedation Study
Acronym
PRO-TEMP Study
Scientific Title
Observational Study on Body Temperature Change in Dental Patients Under Intravenous Sedation
Scientific Title:Acronym
OBS-TEMP Study
Region
| Japan |
Condition
Condition
The study will include patients scheduled for dental treatment under intravenous sedation who fulfill at least one predefined inclusion criterion, do not meet any exclusion criteria, and for whom written informed consent is obtained from the patient or a legally authorized representative.
Classification by specialty
| Anesthesiology | Oral surgery | Operative medicine |
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To describe body temperature changes in patients receiving dental treatment with intravenous sedation.
Basic objectives2
Others
Basic objectives -Others
This study is a non-invasive observational study.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference in tympanic temperature between pre-induction and the end of surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Non-invasive tympanic temperature measurement will be performed using a standard ear thermometer within routine clinical care.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled to undergo dental treatment under intravenous sedation who meet at least one of the following criteria and provide written informed consent (patient or legally authorized representative):
1. Adult patients (>=18 years) with decision-making capacity who provide written informed consent
2. Adult patients (>=18 years) without decision-making capacity whose legally authorized representative provides written informed consent
3. Minor patients (<18 years) judged to lack decision-making capacity whose legally authorized representative provides written informed consent
Key exclusion criteria
Patients will be excluded if they meet any of the following criteria:
1. Patients for whom tympanic temperature measurement with an ear thermometer is judged to be difficult or inappropriate
2. Patients with external ear conditions that may affect tympanic temperature measurement (e.g., otitis externa, tympanic membrane injury)
3. Patients judged by the principal investigator to be unsuitable for participation in this study
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Nagasaki University Hospital
Division name
Department of Dental Anesthesiology
Zip code
852-8501
Address
1-7-1, Sakamoto, Nagasaki, Nagasaki, Japan
TEL
095-819-7714
shtsukimoto@gmail.com
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Nagasaki University Hospital
Division name
Department of dental anesthesiology
Zip code
852-8501
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
TEL
095-821-7714
Homepage URL
s-tsukimoto@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University
Institute
Department
Personal name
Funding Source
Organization
None
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 Research Ethics Committee
Address
1-7-1 Sakamoto, Nagasaki-shi, Nagasaki-ken
Tel
095-819-7229
gaibushikin@ml.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
| 2025 | Year | 12 | 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
| 2025 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 03 | 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
| 2025 | Year | 11 | Month | 25 | Day |
Last modified on
| 2025 | Year | 11 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068418
