UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	studies on the Pathogenesis of Burning Mouth Syndrome
Title of the study (Brief title)	Studies on the Pathogenesis of BMS
Region	Japan

Condition
Condition	Burning Mouth Syndrome
Classification by specialty	Radiology Anesthesiology Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Elucidate the pathogenesis of BMS
Basic objectives2	Others
Basic objectives -Others	Response to the quantitative stimuli
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Specific pain-related sites with fMRI Diffusion of brain signaling by DTI
Key secondary outcomes	Volumetry of brain structures in BMS patients

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	No treatment
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	BMS group: Intervention is applied only on the examination date. Thermal stimuli of 49C and 40 are applied four times each on the right palm or right side of the lower lip.
Interventions/Control_2	Control group: Intervention is applied only on the examination date. The same stimulation to the BMS group is repeated same times at the right palm or right side of the lower lip.
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	38 years-old <
Age-upper limit	68 years-old >=
Gender	Female
Key inclusion criteria	Sore tongue or mouth Feel burning pain in the oral cavity
Key exclusion criteria	Those who are taking anxiolytic drugs or antidepressants. Those who are suffering from brain diseases. Those who have inflammatory diseases in the oral cavity.
Target sample size	40

Research contact person
Name of lead principal investigator	Takahiro Shinozaki
Organization	Nihon University School of Dentistry
Division name	Dept of Oral Diagnostic Sciences
Address	1-8-13 kandasurugadai, chiyoda-ku, Tokyo, Japan
TEL	03-3219-8089
Email	shinozaki.takahiro@nihon-u.ac.jp

Public contact
Name of contact person	Takahiro Shinozaki
Organization	Nihon University School of Dentistry
Division name	Dept of Oral Diagnostic Sciences
Address	1-8-13 kandasurugadai, chiyoda-ku, Tokyo, Japan
TEL	03-3219-8089
Homepage URL
Email	shinozaki.takahiro@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Dentistry
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Department of Radiology,Nihon University School of Medicine
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	日本大学医学部板橋病院

Other administrative information
Date of disclosure of the study information	2014 Year 09 Month 01 Day

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2013 Year 12 Month 14 Day
Anticipated trial start date	2014 Year 01 Month 16 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	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 08 Month 31 Day
Last modified on	2018 Year 03 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000017449