UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020339 |
|---|---|
| Receipt number | R000023482 |
| Scientific Title | Relationship between malocclusion and stress |
| Date of disclosure of the study information | 2015/12/25 |
| Last modified on | 2016/01/05 17:25:33 |
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Basic information
Public title
Relationship between malocclusion and stress
Acronym
Relationship between malocclusion and stress
Scientific Title
Relationship between malocclusion and stress
Scientific Title:Acronym
Relationship between malocclusion and stress
Region
| Japan |
Condition
Condition
Periodontitis
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between masticatory performance and heart rate variability
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
masticatory performance evaluated by using Masticatory Performance Evaluating Gum at the time of heart rate valiability measurement
Key secondary outcomes
heart rate valiability, STAI (state and trait of anxiety), probing pocket depth, clinical attachement level, bleeding on probing, number of teeth present, number of mobile tooth, the presence of a prothesis, occlusion pairs of teeth (Eichner's index)
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
measurement of masticatory performance, biting ability, STAI (state and trait of anxiety), and heart rate variability
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving periodontal maintenance care
Key exclusion criteria
Patients taking the drug related to the heart rate valiability
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Manabu Morita |
Organization
Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Preventive Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
mmorita@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Manabu Morita |
Organization
Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Preventive Dentistry
Zip code
Address
2-5-1, Shikata-cho, Kita-ku, Okayama
TEL
086-235-6712
Homepage URL
mmorita@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Preventive Dentistry, Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department
Personal name
Funding Source
Organization
Grants-in-Aid for Scientific Research from the Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
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 | 12 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/23078535
Number of participants that the trial has enrolled
Results
The high sympathetic activity group showed a significantly lower level of masticatory performance than the low sympathetic activity group.
The result of this study was published in Acta Odontologica Scandinavica.
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
| 2010 | Year | 03 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
| 2011 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2011 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2011 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 25 | Day |
Last modified on
| 2016 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023482
