UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038122 |
|---|---|
| Receipt number | R000043441 |
| Scientific Title | Stress assessment by dental treatment |
| Date of disclosure of the study information | 2019/09/28 |
| Last modified on | 2026/06/30 11:00:44 |
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Basic information
Public title
Stress assessment by dental treatment
Acronym
Stress assessment by dental treatment
Scientific Title
Stress assessment by dental treatment
Scientific Title:Acronym
Stress assessment by dental treatment
Region
| Japan |
Condition
Condition
Dental phobia
gag reflex
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
responses in patients with dental phobia using both physiological and psychological indicators, to elucidate the factors contributing to stress and effective strategies for its reduction, and to translate these findings into clinical dental practice.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The primary outcome measures are physiological and psychological stress indicators, including salivary amylase activity, heart rate, and Visual Analog Scale ratings of stress, anxiety, and pain.
Key secondary outcomes
The secondary outcome measures in this research series were treatment satisfaction, treatment expectations, behavioral changes, and fear and stress ratings related to specific dental procedures and dental environmental factors.
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Presentation of visual color stimuli (blue, green, and red) in the dental treatment environment
Interventions/Control_2
Salivary stress biomarkers, heart rate
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with dental phobia or patients requiring intravenous sedation for dental treatment.
Adults aged 18 years or older.
Patients who provided written informed consent.
Patients who were able to complete the study protocol and outcome assessments.
Key exclusion criteria
Patients younger than 18 years of age
Patients who did not provide written informed consent
Patients who were unable to complete the study protocol or outcome assessments
Patients with severe systemic disease or psychiatric/cognitive disorders that precluded participation in the study
Patients considered unsuitable for participation at the discretion of the principal investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | YUKIHIKO |
| Middle name | |
| Last name | TAKEMURA |
Organization
Graduate School of Dentistry Kanagawa Dental University
Division name
Department of Restorative Dentistry
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
046-822-8854
takemura@kdu.ac.jp
Public contact
Name of contact person
| 1st name | YUKIHIKO |
| Middle name | |
| Last name | TAKEMURA |
Organization
Graduate School of Dentistry Kanagawa Dental University
Division name
Department of Restorative Dentistry
Zip code
238-8580
Address
82 Inaoka-cho, Yokosuka, Kanagawa
TEL
046-822-8854
Homepage URL
takemura@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Kanagawa Dental 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
Kanagawa Dental University
Address
82 Inaoka-cho, Yokosuka, Kanagawa
Tel
046-822-1500
takemura@kdu.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
| 2019 | Year | 09 | Month | 28 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
https://www.mdpi.com/2077-0383/14/19/6745/pdf
Number of participants that the trial has enrolled
Results
Green stimulation significantly reduced salivary alpha-amylase activity before peripheral intravenous cannulation compared with the translucent condition. Green and blue stimulation also significantly reduced pain VAS scores compared with the red and translucent conditions. No significant differences were observed in heart rate or treatment satisfaction.
Results date posted
| 2021 | Year | 11 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2021 | Year | 06 | Month | 01 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 27 | 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
| 2019 | Year | 09 | Month | 26 | Day |
Last modified on
| 2026 | Year | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043441
