UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The protective effects of hydroxyapatite agarose gel on the anti-resorptive-related osteonecrosis of the jaw
Title of the study (Brief title)	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	Masashi TABATA
Organization	Miyakonojo National Hospital
Division name	Department of Oral and Maxillofacial Surgery
Address	5033-1 iwayoshi-cho miyakonojo Miyazaki
TEL	0986234111
Email	tabatam@mac.com

Public contact
Name of contact person	masashi TABATA
Organization	Miyakonojo National Hospital
Division name	Department of Oral and Maxillofacial Surgery
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 01 Month 16 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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