UMIN-CTR Clinical Trial

Basic information
Public title	An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Acronym	An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Scientific Title	An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Scientific Title:Acronym	An exploratory research of the effects of comprehensive oral care, including antibiotics on the tongue, in patients who underwent resection and reconstruction of oral cancer
Region	Japan

Condition
Condition	Oral Cancer
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	consider to Whether comprehensive oral care, including antibiotics on the tongue, is effective in reducing oropharyngeal bacteria (tongue, saliva, and intratracheal invaders) and preventing postoperative complications.
Basic objectives2	Others
Basic objectives -Others	consider to Whether comprehensive oral care, including antibiotics on the tongue, is effective in reducing oropharyngeal bacteria (tongue, saliva, and intratracheal invaders) and preventing postoperative complications.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	effective in reducing oropharyngeal bacteria (tongue, saliva, and intratracheal invaders)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	No treatment
Stratification	YES
Dynamic allocation	NO
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Other
Interventions/Control_1	Application of cetylpyridinium chloride spray
Interventions/Control_2	Untreated control
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	100 years-old >=
Gender	Male and Female
Key inclusion criteria	1Patients who are planning surgery using flaps. 2Patients who undergo surgery under general anesthesia and require a hospital stay of 7 days or more after surgery. 3Patients who agreed to participate in this study.
Key exclusion criteria	1Patients who are judged by the principal investigator to be inappropriate for participation in this research. 2 Patients who are allergic to the drug used. 3 Patients with a high possibility that swallowing function will be significantly impaired (subtotal tongue resection or total tongue resection surgery, etc.) Scheduled patient).
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Kurita
Organization	Shinshu university School of Medicine
Division name	Dentistry and Oral Surgery
Zip code	0900802
Address	Asahi 3-1-1, Matsumoto
TEL	0263-37-2677
Email	hkurita@shinshu-u.ac.jp

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Kurita
Organization	Shinshu university School of Medicine
Division name	Dentistry and Oral Surgery
Zip code	3900802
Address	Asahi 3-1-1, Matsumoto
TEL	0263-37-2677
Homepage URL
Email	hkurita@shinshu-u.ac.jp

Sponsor
Institute	Dept.of Dentistry and Oral Surgery,Shinshu University School of Medicine
Institute
Department

Funding Source
Organization	No
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Shinshu university School of Medicine
Address	Asahi 3-1-1, Matsumoto
Tel	0263-37-2677
Email	shinshu-u.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	信州大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2021 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2021 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date	2021 Year 08 Month 01 Day
Last follow-up date	2026 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 07 Month 21 Day
Last modified on	2021 Year 07 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051265