UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057902 |
|---|---|
| Receipt number | R000059375 |
| Scientific Title | Evaluation of quality of life and oral function in patients with drug-related osteonecrosis of the jaw |
| Date of disclosure of the study information | 2025/05/19 |
| Last modified on | 2025/05/19 11:36:36 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of quality of life and oral function in patients with drug-related osteonecrosis of the jaw
Acronym
Evaluation of quality of life and oral function in patients with drug-related osteonecrosis of the jaw
Scientific Title
Evaluation of quality of life and oral function in patients with drug-related osteonecrosis of the jaw
Scientific Title:Acronym
Evaluation of quality of life and oral function in patients with drug-related osteonecrosis of the jaw
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
There are two treatment options for drug-related osteonecrosis of the jaw (MRONJ): conservative and surgical. The choice is divided by stage, but the choice of treatment is ultimately the patient's own. However, if surgical therapy is chosen, loss of teeth, removal of the jawbone, and numbness of the lips may occur, resulting in functional decline. However, there are few reports discussing the treatment of MRONJ in terms of QOL. Therefore, in this study, we decided to investigate oral function and patient satisfaction by treatment method and by surgical method.
Basic objectives2
Others
Basic objectives -Others
Auxiliary Information for Patient Treatment Choice
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
FACT H&N scores by treatment
Key secondary outcomes
Oral function tests by treatment
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age 20 or older at the time of consent
Outpatient/Inpatient: No questions asked
Gender: any or male or female
Diagnosed with drug-related osteonecrosis of the jaw
Patients who have received a thorough explanation of their participation in this study, and who have given their free and voluntary consent based on a thorough understanding of the subject's condition.
Key exclusion criteria
Patients with surgical recurrence
Patients who refused to participate in this study
Other patients deemed inappropriate as research subjects by the principal investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Kansai medical university medical center
Division name
Oral surgery
Zip code
5708507
Address
10-15 Fumizono-cho Moriguchi-shi
TEL
06699639420
s.yukioutdoor@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Sakamoto |
Organization
Kansai medical university medical center
Division name
Oral surgery
Zip code
5708507
Address
10-15 Fumizono-cho Moriguchi-shi
TEL
06699639420
Homepage URL
s.yukioutdoor@gmail.com
Sponsor or person
Institute
Kansai medical university
Institute
Department
Personal name
Funding Source
Organization
Kansai medical university
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kansai medical university medical center
Address
10-15 Fumizono-cho Moriguchi-shi
Tel
06699639420
s.yukioutdoor@gmail.com
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 | 05 | Month | 19 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 03 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2024 | Year | 03 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
nothing
Management information
Registered date
| 2025 | Year | 05 | Month | 19 | Day |
Last modified on
| 2025 | Year | 05 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059375
