UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061740 |
|---|---|
| Receipt number | R000070061 |
| Scientific Title | A study on the evaluation of physiological responses to stress during dental treatment |
| Date of disclosure of the study information | 2026/05/29 |
| Last modified on | 2026/05/29 17:33:12 |
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Basic information
Public title
A study to investigate stress and physiological responses during dental treatment
Acronym
DentStress Study
Scientific Title
A study on the evaluation of physiological responses to stress during dental treatment
Scientific Title:Acronym
D-PSR Study
Region
| Japan |
Condition
Condition
Stress responses during dental treatment
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate physiological responses to stress during dental treatment and to examine the feasibility of objectively assessing stress states.
Basic objectives2
Others
Basic objectives -Others
To investigate the association between physiological indicators measured during dental treatment and subjective stress, and to explore the feasibility of objectively estimating stress states.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The association between continuously measured subjective stress ratings and electrodermal activity during dental treatment
Key secondary outcomes
The association between continuously measured subjective stress ratings and skin temperature during dental treatment
The association between continuously measured subjective stress ratings and heart rate variability during dental treatment
The accuracy of stress estimation using physiological indicators (electrodermal activity, skin temperature, heart rate variability, etc.) during dental treatment
Changes in physiological indicators across treatment phases (resting, vacuum noise exposure, and scaling)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver | Other |
Interventions/Control_1
A single dental treatment session will be performed. In healthy volunteers, supragingival scaling of the mandibular anterior teeth using an ultrasonic scaler will be performed once.
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
| 18 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Participants who provided written informed consent, either personally or via a legally authorized representative.
Key exclusion criteria
Refusal to participate in the study by the participant or a legally authorized representative.
Any individual judged by the investigator or study personnel to be unsuitable for study participation.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Jumpei |
| Middle name | |
| Last name | MURAKAMI |
Organization
The University of Osaka
Division name
Dental Hospital
Zip code
5650871
Address
1-8 Yamada-oka, Suita, Osaka, Japan
TEL
0668792280
murakami.jumpei.dent@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Jumpei |
| Middle name | |
| Last name | Murakami |
Organization
The University of Osaka
Division name
Division of Special Care Dentistry, Dental Hospital
Zip code
5650871
Address
1-8 Yamada-oka, Suita, Osaka, Japan
TEL
06-6879-2280
Homepage URL
murakami.jumpei.dent@osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Daikin Industries, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of the Graduate School of Dentistry, School of Dentistry, and Dental Hospital, The University of Osaka
Address
1-8 Yamada-oka, Suita, Osaka, Japan
Tel
0668795111
murakami.jumpei.dent@osaka-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
| 2026 | Year | 05 | Month | 29 | 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
15
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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2022 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2022 | Year | 06 | Month | 17 | Day |
Last follow-up date
| 2027 | 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
| 2026 | Year | 05 | Month | 29 | Day |
Last modified on
| 2026 | Year | 05 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070061
