UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Confirmatory Trial to Evaluate the Hydroxyapatite Layer Formed by Powder Jet Deposition for Treatment of Dentin Hypersensitivity
Title of the study (Brief title)	Confirmatory Trial to Evaluate the Hydroxyapatite Layer for Treatment of Dentin Hypersensitivity
Region	Japan

Condition
Condition	Dentin Hypersensitivity
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We plan to conduct confirmatory trial for treatment of dentin hypersensitivity and obtain of pharmaceutical approval.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Air pain
Key secondary outcomes	Abrasion pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Formation of hydroxyapatite film
Interventions/Control_2	Treatment of teethmate-desensitizer
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	1. Equal or more than 20 years old at the time of informed concent. 2. Agreement with written informed concent. 3. Capable of going to the hospital regularly 4. Drntal hypersensitivity:VAS>=30, split mouse design 5. Agreement with no treatment next to the test teeth
Key exclusion criteria	1. Patients who have oral mucosal diseases 2. Past medical history about adverse effects of local anesthetic 3. Pregnancy or possibility of pregnancy 4. Participants of other clinical trial 5. Taking painkillers 6. Patients who are judged as in adequate for this trial by the investigators
Target sample size	35

Research contact person
Name of lead principal investigator	Keiichi Sasaki
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Advanced Prosthetic Dentistry
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-8369
Email	keii@dent.tohoku.ac.jp

Public contact
Name of contact person	Kuniyuki Izumita
Organization	Tohoku University Graduate School of Dentistry
Division name	Division of Advanced Prosthetic Dentistry
Address	4-1, Seiryo-machi, Aoba-ku, Sendai, Miyagi
TEL	022-717-8369
Homepage URL
Email	k-izumita@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku University Graduate School of Dentistry
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 12 Month 02 Day

Progress
Recruitment status
Date of protocol fixation	2016 Year 12 Month 15 Day
Anticipated trial start date	2016 Year 12 Month 15 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	2016 Year 11 Month 28 Day
Last modified on	2017 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028793