臨床研究等提出・公開システム

Scientific Title	Multicenter study of effects of topical fluoride application with tray on prevention of dental caries in patients undergoing head and neck radiotherapy
Public Title	Prevention of radiation induced dental caries by topical fluoride with tray

Contact for Scientific Queries	Name	Soutome Sakiko
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi
	Telephone	+81-95-819-7663
	E-mail	sakiko@nagasaki-u.ac.jp
Contact for Public Queries	Name	Soutome Sakiko
	Affiliation	Nagasaki University Hospital
	Address	1-7-1 Sakamoto, Nagasaki-shi
	Telephone	+81-95-819-7663
	E-mail	sakiko@nagasaki-u.ac.jp

Recruitment status	Not Recruiting

Anticipated date of first enrollment		July. 01, 2020
Actual date of first enrollment		July. 13, 2020
Target sample size		80
Study Type		Interventional
Study Design	allocation	randomized controlled trial
	masking	open(masking not used)
	control	no treatment control/standard of care control
	assignment	parallel assignment
	purpose	prevention purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with head and neck cancer undergoing chemo-radiotherapy
	Exclusion Criteria	Patients with problem in judgement
	Age Minimum	20age old over
	Age Maximum	89age old under
	Gender	Both
Health Condition(s) or Problem(s) Studied		Head and neck cancer
Intervention(s)		Custom tray with tooth paste containing 1450 ppm fluoride is attached at bedtime everyday for one year.
Health Condition(s) Keyword		head and neck cancer, radiation-induced dental caries
Intervention(s) Keyword
Health Condition(s) Code
Intervention(s) Code
Primary Outcome(s)		Prevention of radiation-induced dental caries
Secondary Outcome(s)		Investigation of factors related to development of radiation induced dental caries

Primary Sponsor

Source of Monetary Support / Secondary Sponsor
Secondary Sponsor

Source of Monetary Support
Secondary Sponsor

Name of Certified Review Board	The Clinical Research Review Board in Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki-shi, Nagasaki
Telephone	+81-95-819-7905
E-Mail	gaibushikin@ml.nagasaki-u.ac.jp
Approval Status	Approval
Date of approval	Dec. 25, 2019

Secondary ID(s)
Issuing Authority

Countries of Recruitment（Except Japan）	none

History of Changes

List of change history