UMIN-CTR Clinical Trial

Basic information
Public title	The study of adhesion effect of hypersensitivity inhibitors on the tooth surface
Acronym	The study of adhesion effect of hypersensitivity inhibitors
Scientific Title	The study of adhesion effect of hypersensitivity inhibitors on the tooth surface
Scientific Title:Acronym	The study of adhesion effect of hypersensitivity inhibitors
Region	Japan

Condition
Condition	hypersensitivity
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Adhesion efficiency of hypersensitivity inhibitors with novel monomers is investigated.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A hypersensitivity inhibitor with coloring agent is applied to the tooth surface and photographed every week to determine the efficiency of adhesion.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
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	Medicine
Interventions/Control_1	BioCoat Ca (Medical Devices Agency: 230AKBZX00059000) with colorant is applied to the tooth surface only once.
Interventions/Control_2	Every week, intraoral photos are taken. Photography is for a maximum of one year.
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	22 years-old <=
Age-upper limit	55 years-old >=
Gender	Male and Female
Key inclusion criteria	The population is healthy adults in the university who applied by displaying posters.
Key exclusion criteria	Have an apparently malocclusion or caries. Those determined by the physician in the case to be inappropriate for inclusion in this study.
Target sample size	13

Research contact person
Name of lead principal investigator	1st name Satoshi Middle name Last name Fukumoto
Organization	Tohoku Univ. Kyushu Univ.
Division name	Pediatric Dent.
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
TEL	022-717-8382
Email	fukumoto@dent.tohoku.ac.jp

Public contact
Name of contact person	1st name Kan Middle name Last name Saito
Organization	Tohoku Univ.
Division name	Pediatric Dent.
Zip code	980-8575
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
TEL	022-717-8382
Homepage URL
Email	kanta@dent.tohoku.ac.jp

Sponsor
Institute	Tohoku Univ.
Institute
Department

Funding Source
Organization	Self funding
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Tohoku University Graduate School of Dentistry
Address	4-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi,
Tel	022-717-8244
Email	rinri-esct@proj.med.tohoku.ac.jp

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	2022 Year 03 Month 31 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	https://www.mdpi.com/1996-1944/15/15/5172
Number of participants that the trial has enrolled	13
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results	2022 Year 07 Month 26 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Main results already published
Date of protocol fixation	2021 Year 06 Month 25 Day
Date of IRB	2020 Year 07 Month 03 Day
Anticipated trial start date	2021 Year 07 Month 01 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded	2022 Year 07 Month 26 Day

Other
Other related information

Management information
Registered date	2021 Year 07 Month 05 Day
Last modified on	2022 Year 07 Month 28 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000050997