UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032091 |
|---|---|
| Receipt number | R000036466 |
| Scientific Title | The protective effects of hydroxyapatite agarose gel on the anti-resorptive-related osteonecrosis of the jaw |
| Date of disclosure of the study information | 2018/04/09 |
| Last modified on | 2018/04/03 20:41:27 |
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Basic information
Public title
The protective effects of hydroxyapatite agarose gel on the anti-resorptive-related osteonecrosis of the jaw
Acronym
The effects of hydroxyapatite agarose gel on the anti-resorptive-related osteonecrosis of the jaw
Scientific Title
The protective effects of hydroxyapatite agarose gel on the anti-resorptive-related osteonecrosis of the jaw
Scientific Title:Acronym
The effects of hydroxyapatite agarose gel on the anti-resorptive-related osteonecrosis of the jaw
Region
| Japan |
Condition
Condition
medication-related osteonecrosis of the jaws
Classification by specialty
| Oral surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to study the effect of hydroxyapatite biodegradable polymer for prevention and treatment on the medication-related osteonecrosis of the jaws
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Phase I,II
Assessment
Primary outcomes
Radiographic evaluation is performed at 6 and 12-months after surgery. Osteolysis, cortical bone erosion, bone sclerosis focal and diffuse sclerosis, bone sequestration, thickening of the lamina dura, persisting alveolar sockets, and the presence of pathological fracture.
Key secondary outcomes
Comprehensive oral examination is preformed.
The outcome is classified into one of the following
three categories; healing, improvement, unchanged, and exacerbation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Medication-related osteonecrosis(MRONJ) is maxillary and mandibular osteonecrosis related not only to bisphosphonates but also to other antiresorptive agents such as denosumab and antiangiogenic drugs. Stage 2 disease is characterised by exposed bone with pain, adjacent or regional soft tissue inflammatory swelling or secondary infection. Patients with Stage 3 disease have exposed bone associated with pain, adjacent or regional soft tissue inflammatory swelling or sexondary infection in addition to a pathologic fracture, or an extra-oral/oral antral fistula or radiographic evidence of osteolysis extending to the inferior border or sinus floor.
The patients with Stage 2 or 3 were included in this study. The sequestrum is removed with surrounding vital bone. In the test group, hydroxyapatite biodegradable polymer was filled into the bony defect.
Interventions/Control_2
In the control group, no filling material was used
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Stage 2 and 3 of medication-related osteonecrosis of the jaws
Key exclusion criteria
Patients with a history of either radiation therapy to the head and neck region or neoplasms (including metastasis) involving the head and neck
region are excluded.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masashi TABATA |
Organization
Miyakonojo National Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
5033-1 iwayoshi-cho miyakonojo Miyazaki
TEL
0986234111
tabatam@mac.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | masashi TABATA |
Organization
Miyakonojo National Hospital
Division name
Department of Oral and Maxillofacial Surgery
Zip code
Address
5033-1 iwayoshi-cho miyakonojo Miyazaki
TEL
0986234111
Homepage URL
tabatam@mac.com
Sponsor or person
Institute
Miyakonojo National Hospital
Department of Oral and Maxillofacial Surgery
Institute
Department
Personal name
Funding Source
Organization
BMT hybrid
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
独立行政法人国立病院機構都城医療センター歯科口腔外科
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 09 | 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
| 2018 | Year | 01 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 02 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 05 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 04 | Month | 03 | Day |
Last modified on
| 2018 | Year | 04 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036466
