UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041426 |
|---|---|
| Receipt number | R000047294 |
| Scientific Title | Multicenter study of effects of topical fluoride application with tray on prevention of dental caries in patients undergoing head and neck radiotherapy |
| Date of disclosure of the study information | 2020/08/15 |
| Last modified on | 2023/05/01 12:44:48 |
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Basic information
Public title
Multicenter study of effects of topical fluoride application with tray on prevention of dental caries in patients undergoing head and neck radiotherapy
Acronym
Prevention of radiation induced dental caries by topical fluoride with tray
Scientific Title
Multicenter study of effects of topical fluoride application with tray on prevention of dental caries in patients undergoing head and neck radiotherapy
Scientific Title:Acronym
Prevention of radiation induced dental caries by topical fluoride with tray
Region
| Japan |
Condition
Condition
Head and neck cancer
Classification by specialty
| Oral surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Prevention of radiation-induced dental caries
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevention of radiation-induced dental caries
Key secondary outcomes
Investigation of factors related to development of radiation induced dental caries
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Custom tray with tooth paste containing 1450 ppm fluoride is attached at bedtime everyday for one year
Interventions/Control_2
No custom tray with tooth paste containing 1450 ppm fluoride is attached at bedtime everyday for 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
| 20 | years-old | <= |
Age-upper limit
| 89 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with head and neck cancer undergoing chemo-radiotherapy
Key exclusion criteria
Patients with problem in judgement
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Hospital
Division name
Oral Care Center
Zip code
852-8511
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7663
sakiko@nagasaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Sakiko |
| Middle name | |
| Last name | Soutome |
Organization
Nagasaki University Hospital
Division name
Oral Care Center
Zip code
852-8511
Address
1-7-1 Sakamoto, Nagasaki-shi
TEL
095-819-7663
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
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Clinical Research Review Board in Nagasaki University
Address
1-7-1 Sakamoto, Nagasaki-shi
Tel
095-819-7229
gaibushikin@ml.nagasaki-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
jRCTs 072190039
Org. issuing International ID_1
jRCT
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 08 | Month | 15 | 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
yes
IPD sharing Plan description
The study investigators will have full access to and ownership of all data. De-identified data will be made available to outside investigators for additional analyses, upon reasonable request, following reports of primary outcomes, and with appropriate data use agreement. The findings in this study will be disseminated through scientific and professional conferences, and in peer-reviewed journal.
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2020 | Year | 01 | Month | 07 | Day |
Date of IRB
| 2019 | Year | 12 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 12 | 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
| 2020 | Year | 08 | Month | 15 | Day |
Last modified on
| 2023 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047294
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
