UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Gingival blood flow measurement using laser Doppler flowmetry under occlusal trauma
Title of the study (Brief title)	Gingival blood flow measurement using laser Doppler flowmetry under occlusal trauma
Region	Japan

Condition
Condition	malocclusion, periodontal disease
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify gingival blood flow changes under the condition of the occlusal trauma
Basic objectives2	Others
Basic objectives -Others	To understand the effect of the orthodontic treatment on the periodontal tissue
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	occlusal force, tooth mobility, gingival blood flow, gingival blood mass, gingival blood velocity
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	12 years-old <=
Age-upper limit	60 years-old >=
Gender	Male and Female
Key inclusion criteria	malocclusion normal occlusion
Key exclusion criteria	hypertension smoker
Target sample size	30

Research contact person
Name of lead principal investigator	KenjiFushima
Organization	Yokohama Clinic, Kanagawa Dental University
Division name	Division of Orthodontics, Dept.of Highly Advanced Stomatology
Address	Tsuruya-cho 3-31-6, Kanagawa-ku, Yokohama
TEL	045-313-4019
Email	fushima@kdu.ac.jp

Public contact
Name of contact person	KenjiFushima
Organization	Yokohama Clinic, Kanagawa Dental University
Division name	Division of Orthodontics, Dept.of Highly Advanced Stomatology
Address	Tsuruya-cho 3-31-6, Kanagawa-ku, Yokohama
TEL	045-313-4019
Homepage URL
Email	fushima@kdu.ac.jp

Sponsor
Institute	Graduate School of Dentistry, Kanagawa Dental University
Institute
Department

Funding Source
Organization	Graduate School of Dentistry, Kanagawa Dental University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 01 Month 26 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2017 Year 02 Month 17 Day
Anticipated trial start date	2017 Year 08 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
Other related information	Nothing particular

Management information
Registered date	2018 Year 01 Month 26 Day
Last modified on	2018 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035201