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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020339
Receipt No. R000023482
Scientific Title Relationship between malocclusion and stress
Date of disclosure of the study information 2015/12/25
Last modified on 2016/01/05

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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
Email 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
Email mmorita@md.okayama-u.ac.jp

Sponsor
Institute Department of Preventive Dentistry, Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023482

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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