UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053943 |
|---|---|
| Receipt number | R000061569 |
| Scientific Title | Crossover study on stress response during impression taking |
| Date of disclosure of the study information | 2024/03/25 |
| Last modified on | 2024/03/22 16:09:01 |
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Basic information
Public title
Research on stress response during dental treatment
Acronym
Stress response during dental treatment
Scientific Title
Crossover study on stress response during impression taking
Scientific Title:Acronym
Stress response during impression taking
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the stress response between optical and conventional impression taking during dental treatment
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cardiac autonomic nervous system response
Galvanic skin response
Key secondary outcomes
psychological evaluation
Salivary alpha-amylase determination
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Optical impression taking with intraoral scanner
Interventions/Control_2
Taking impressions with alginate
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
Healthy adults aged 18-59
Key exclusion criteria
Individuals with severe periodontal disease or temporomandibular disorder
Individuals with dentures or bridges
Individuals undergoing dental or orthodontic treatment
Individuals with significant dental irregularities
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ayuko |
| Middle name | |
| Last name | Okamoto |
Organization
Nippon Dental University, School of Life Dentistry
Division name
Department of Pediatric Dentistry
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku Tokyo
TEL
03-3261-8311
okamotoa@tky.ndu.ac.jp
Public contact
Name of contact person
| 1st name | Ayuko |
| Middle name | |
| Last name | Okamoto |
Organization
Nippon Dental University, School of Life Dentistry
Division name
Department of Pediatric Dentistry
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku Tokyo
TEL
03-3261-8311
Homepage URL
okamotoa@tky.ndu.ac.jp
Sponsor or person
Institute
Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
Scientific Research from the Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Nippon Dental University, School of Life Dentistry
Address
1-9-20 Fujimi Chiyoda-ku Tokyo
Tel
03-3261-8311
ndu-rinri@tky.ndu.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
日本歯科大学生命歯学部小児歯科学講座
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 03 | Month | 25 | 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
| 2021 | Year | 10 | Month | 27 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2026 | 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
| 2024 | Year | 03 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000061569
