UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024084 |
|---|---|
| Receipt number | R000027702 |
| Scientific Title | The effect of dental topical anesthetic with aroma. |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2024/06/28 10:07:18 |
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Basic information
Public title
The effect of dental topical anesthetic with aroma.
Acronym
The effect of dental topical anesthetic with aroma.
Scientific Title
The effect of dental topical anesthetic with aroma.
Scientific Title:Acronym
The effect of dental topical anesthetic with aroma.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The porpose of this study is to investigate the effect of dental topical anesthetic with aroma for dental anxiety.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
State-Trait Anxiety Inventory (STAI)
Key secondary outcomes
Blood pressure, Heart rate, Oxygen saturation of peripheral artery, Heart Rate Variability, Visual Analogue Scale, Salivary amylase, Questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
2% Lidocaine jelly is selected as a topical anesthetics.
Interventions/Control_2
Prones-pasta-aroma is selected as a topical anesthetics.
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
Healty volunteers
Key exclusion criteria
1,Ethyl aminobenzoate allergy
2,Lidocaine allergy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sunada |
Organization
The Nippon Dental University
Division name
Dental Anesthesiology
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku Tokyo Japan
TEL
03-3261-6083
katsu.sunada@nifty.com
Public contact
Name of contact person
| 1st name | Yukako |
| Middle name | |
| Last name | Tsutsui |
Organization
The Nippon Dental University
Division name
Dental Anesthesiology
Zip code
102-8159
Address
1-9-20 Fujimi Chiyoda-ku Tokyo Japan
TEL
03-3261-6083
Homepage URL
tsutsuiy@tky.ndu.ac.jp
Sponsor or person
Institute
The Nippon Dental University
Institute
Department
Personal name
Funding Source
Organization
Nippon Shika Yakuhin Co.,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
The Nippon Dental University
Address
1-9-20 Fujimi Chiyoda-ku Tokyo Japan
Tel
03-3261-6083
tsutsuiy@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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://onlinelibrary.wiley.com/doi/10.1002/ffj.3467
Publication of results
Published
Result
URL related to results and publications
https://onlinelibrary.wiley.com/doi/10.1002/ffj.3467
Number of participants that the trial has enrolled
68
Results
Patients do not experience increased anxiety when using dental topical anaesthetic with their preferred aroma prior to dental local anesthesia.
Results date posted
| 2024 | Year | 06 | Month | 28 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Volunteers
Participant flow
Volunteers
Adverse events
No
Outcome measures
Vital signs, State trait anxiety inventory, Visual analogue scale, Heart rate variability
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 09 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 12 | Month | 27 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 27 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 27 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 06 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027702
