UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002509 |
|---|---|
| Receipt number | R000003069 |
| Scientific Title | Observational study on the control of development of dental caries by MI paste(CPP-ACP) for radiation xerostomia patients. |
| Date of disclosure of the study information | 2009/09/17 |
| Last modified on | 2012/04/19 17:23:41 |
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Basic information
Public title
Observational study on the control of development of dental caries by MI paste(CPP-ACP) for radiation xerostomia patients.
Acronym
Observational study on the control of development of dental caries by MI paste(CPP-ACP) for radiation xerostomia patients.
Scientific Title
Observational study on the control of development of dental caries by MI paste(CPP-ACP) for radiation xerostomia patients.
Scientific Title:Acronym
Observational study on the control of development of dental caries by MI paste(CPP-ACP) for radiation xerostomia patients.
Region
| Japan |
Condition
Condition
Radiation xerostomia
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Purpose of this study are to evaluate the control of dental caries by CPP-ACP for radiation xerostomia patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Control of dental caries
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Head and neck cancer patients with radiation xerostomia.
Key exclusion criteria
Patients with loco-regional recurrence and/ or distant metastasis.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouji Katsura |
Organization
Niigata University Medical and Dental Hospital
Division name
Oral and Maxillofacial Radiology
Zip code
Address
1-754 Asahimachi-dori Chuo-ku Niigata City
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Niigata University Medical and Dental Hospital Dental Department
Division name
Oral and Maxillofacial Radiology
Zip code
Address
TEL
Homepage URL
katsu@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital Dental Department
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
GC CORPORATION
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
| 2009 | Year | 09 | Month | 17 | Day |
Related information
URL releasing protocol
http://canceroralcareworkshop.web.fc2.com/doing.htm
Publication of results
Partially published
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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1) The incidence of dental caries.
2) The incidence of remineralization.
Management information
Registered date
| 2009 | Year | 09 | Month | 16 | Day |
Last modified on
| 2012 | Year | 04 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003069
| 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 |
