UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017221 |
|---|---|
| Receipt number | R000019964 |
| Scientific Title | The study of relieving pain during orthodontic treatment with aromatherapy |
| Date of disclosure of the study information | 2015/04/21 |
| Last modified on | 2015/04/21 20:44:06 |
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Basic information
Public title
The study of relieving pain during orthodontic treatment with aromatherapy
Acronym
The study of relieving pain during orthodontic treatment with aromatherapy
Scientific Title
The study of relieving pain during orthodontic treatment with aromatherapy
Scientific Title:Acronym
The study of relieving pain during orthodontic treatment with aromatherapy
Region
| Japan |
Condition
Condition
Malocclusion
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Aromatherapy evaluate a mild effect on toothache and discomfort with the tooth movement in the orthodontic treatment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
VAS change before and after the aromatherapy intervention
Key secondary outcomes
Quantity of oxidation hemoglobin, quantity of reduction hemoglobin
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Aromatherapy (lavender)
Interventions/Control_2
Aromatherapy (peppermint)
Interventions/Control_3
Control (purified water)
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
Patients who need separation of teeth for forming band
Key exclusion criteria
Patient without the opposing tooth of the maxillary first molar
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoo Kaneko |
Organization
Hokkaido University Hospital
Division name
Center for Advanced Oral Medicine
Zip code
Address
Kita 14 Nishi 5 Kita-ku Sapporo Hokkaido
TEL
011-706-4287
tmkaneko@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoo Kaneko |
Organization
Hokkaido University Hospital
Division name
Orthodontics
Zip code
Address
Kita 14 Nishi 5 Kita-ku Sapporo Hokkaido
TEL
011-806-4287
Homepage URL
tmkaneko@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital Clinical Research and Medical Innovation Center
Institute
Department
Personal name
Funding Source
Organization
AROMA Environment association of Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2015 | Year | 04 | Month | 21 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2012 | Year | 09 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2015 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 21 | Day |
Last modified on
| 2015 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019964
