UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058621 |
|---|---|
| Receipt number | R000067031 |
| Scientific Title | Relationships of variations in the oral microbiota and patients with medication-related osteonecrosis of the jaw |
| Date of disclosure of the study information | 2025/08/01 |
| Last modified on | 2025/07/28 20:19:48 |
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Basic information
Public title
Relationships of variations in the oral microbiota and patients with medication-related osteonecrosis of the jaw
Acronym
Relationships of variations in the oral microbiota and patients with MRONJ
Scientific Title
Relationships of variations in the oral microbiota and patients with medication-related osteonecrosis of the jaw
Scientific Title:Acronym
Relationships of variations in the oral microbiota and patients with MRONJ
Region
| Japan |
Condition
Condition
Medication-related osteonecrosis of the jaw
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify the trend of oral microbiota imbalance in patients with MRONJ.
Basic objectives2
Others
Basic objectives -Others
This study clarifies the differences in oral microbiota community types between normal subjects and MRONJ patients.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Extract DNA from saliva of MRONJ patients and perform a comprehensive analysis of bacterial species. Bacterial species are clustered and analyzed for trends in balance abnormalities specific to MRONJ patients.
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
In a single-arm study, a single sample of saliva is collected from MRONJ patients.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients diagnosed with MRONJ who are at least 18 years of age
Key exclusion criteria
Patients under 18 years of age and without sufficient judgment
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Kento |
| Middle name | |
| Last name | Kaminogo |
Organization
Nagoya University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
466-8560
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2348
kaminogo.kento.r3@f.mail.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | Kento |
| Middle name | |
| Last name | Kaminogo |
Organization
Nagoya University Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
466-8550
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
0527442348
Homepage URL
kaminogo.kento.r3@f.mail.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Review Committee of Nagoya University Graduate School of Medicine
Address
65 Tsurumai-cho, Showa-ku, Nagoya
Tel
052-744-2777
ethics@med.nagoya-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 | 08 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 07 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2029 | Year | 03 | 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
| 2025 | Year | 07 | Month | 28 | Day |
Last modified on
| 2025 | Year | 07 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067031
