UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025196 |
|---|---|
| Receipt number | R000028984 |
| Scientific Title | Topical application of fluoride by tray method for prevention of multiple tooth caries after radiotherapy in patients with head and neck cancer |
| Date of disclosure of the study information | 2017/01/04 |
| Last modified on | 2019/12/14 23:08:19 |
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Basic information
Public title
Topical application of fluoride by tray method for prevention of multiple tooth caries after radiotherapy in patients with head and neck cancer
Acronym
Prevention of caries after radiotherapy
Scientific Title
Topical application of fluoride by tray method for prevention of multiple tooth caries after radiotherapy in patients with head and neck cancer
Scientific Title:Acronym
Prevention of caries after radiotherapy
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oto-rhino-laryngology | Radiology | Oral surgery |
| Dental medicine | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the efficacy of topical fluoride on tooth caries prevention after radiotherapy in patients with head and neck cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
development of tooth caries
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Application of fluoride by tray
Interventions/Control_2
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
Patients with head and neck cancer who undergo radiotherapy of 50Gy or more
Key exclusion criteria
Patients having 10 teeth or less
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Sakiko Soutome |
Organization
Nagasaki University Hospital
Division name
Perioperative Oral Management Center
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7698
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Sakiko Soutome |
Organization
Nagasaki University Hospital
Division name
Perioperative Oral Management Center
Zip code
Address
1-7-1, Sakamoto, Nagasaki
TEL
095-819-7698
Homepage URL
sakiko@nagasaki-u.ac.jp
Sponsor or person
Institute
Nagasaki University Hospital
Institute
Department
Personal name
Funding Source
Organization
Nagasaki University Hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 01 | Month | 04 | 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
10
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
Completed
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 27 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 09 | Day |
Last modified on
| 2019 | Year | 12 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028984
