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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000032091
Receipt No. 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

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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
Email 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
Email tabatam@mac.com

Sponsor
Institute Miyakonojo National Hospital
Department of Oral and Maxillofacial Surgery
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036466

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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