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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002509
Receipt No. 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

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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
Email

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
Email katsu@dent.niigata-u.ac.jp

Sponsor
Institute Niigata University Medical and Dental Hospital Dental Department
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003069

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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