UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057019 |
|---|---|
| Receipt number | R000065168 |
| Scientific Title | A prospective study to identify risk factors for dental caries after head and neck radiation therapy |
| Date of disclosure of the study information | 2025/02/13 |
| Last modified on | 2025/02/13 18:44:43 |
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Basic information
Public title
A prospective study to identify risk factors for dental caries after head and neck radiation therapy
Acronym
Study on dental caries after radiotherapy
Scientific Title
A prospective study to identify risk factors for dental caries after head and neck radiation therapy
Scientific Title:Acronym
A prospective study on dental caries after radiotherapy
Region
| Japan |
Condition
Condition
Dental caries
Classification by specialty
| Dental medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To prospectively investigate the relationship between dental caries and radiation dose to the tooth/oral environment.
Basic objectives2
Others
Basic objectives -Others
risk factor
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
incidence of dental caries after radiotherapy
Key secondary outcomes
change in the oral environment
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
| 20 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with head and neck cancer who are scheduled to receive new radiation therapy during the study period.
2) Patients with at least one healthy tooth.
Key exclusion criteria
1) Postoperative radiation therapy
2) Preoperative radiation therapy patients
3) Edentulous patients
Target sample size
35
Research contact person
Name of lead principal investigator
| 1st name | Katsura |
| Middle name | |
| Last name | Kouji |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Oral Radiology
Zip code
951-8520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
TEL
0252272915
katsu@dent.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Katsura |
| Middle name | |
| Last name | Kouji |
Organization
Niigata University Medical and Dental Hospital
Division name
Department of Oral Radiology
Zip code
951-8520
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
TEL
0252272915
Homepage URL
katsu@dent.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University Medical and Dental Hospital
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Niigata University Medical and Dental Hospital
Address
1-754 Asahimachi-dori, Chuo-ku, Niigata City, Niigata
Tel
0252272915
katsu@dent.niigata-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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 02 | Month | 13 | 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
Suspended
Date of protocol fixation
| 2023 | Year | 08 | Month | 31 | Day |
Date of IRB
| 2023 | Year | 08 | Month | 31 | Day |
Anticipated trial start date
| 2023 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Collaborative observational research with National Cancer Center Hospital and Tohoku University
Management information
Registered date
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065168
