UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of dental implant treatment for patients taking bone resorption inhibitors and angiogenesis inhibitors
Acronym	Clinical study of dental implant treatment for patients taking bone resorption inhibitors and angiogenesis inhibitors
Scientific Title	Clinical study of dental implant treatment for patients taking bone resorption inhibitors and angiogenesis inhibitors
Scientific Title:Acronym	Clinical study of dental implant treatment for patients taking bone resorption inhibitors and angiogenesis inhibitors
Region	Japan

Condition
Condition	missing teeth
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This is a clinical study of bone regeneration ability in bone gain in the case of alveolar bone defect or lack of bone mass in dental implant treatment. The purpose of this study is to scientifically prove that dental implant treatment can lead to recovery of masticatory power even in patients taking bone resorption inhibitors and angiogenesis inhibitors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The PDI (probing pocket depth) around the dental implant after implantation is measured to evaluate the inflammation of the surrounding gingiva. In addition, the presence or absence of exposed bone drainage is evaluated from macroscopic findings.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	no Intervention
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	Patients who have a history of oral administration of bone resorption inhibitors and angiogenesis inhibitors and wish to receive dental implant treatment and can collaborate in research.
Key exclusion criteria	Patients who are considered to have physical difficulty in implanting dental implants due to absorption of the ridge. Other patients who are considered to prefer prosthetic treatment with dentures or bridges rather than dental implant treatment.
Target sample size	50

Research contact person
Name of lead principal investigator	1st name kazuya Middle name Last name inoue
Organization	Osaka Medical and Pharmaceutical University
Division name	oral surgery
Zip code	569-8686
Address	2-7 Daigakumachi .takatsuki city
TEL	0726831221
Email	kazuya.inoue@ompu.ac.jp

Public contact
Name of contact person	1st name kazuya Middle name Last name inoue
Organization	osaka medical and Pharmaceutical University
Division name	oral surgery
Zip code	569-8686
Address	2-7 Daigakumachi .takatsuki city
TEL	0726831221
Homepage URL
Email	kazuya.inoue@ompu.ac.jp

Sponsor
Institute	Osaka Medical and Pharmaceutical University
Institute
Department

Funding Source
Organization	Osaka Medical and Pharmaceutical 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	Faculty of oral surgery.osaka medical and Pharmaceutical University
Address	osaka. takatsuki
Tel	0726831221
Email	kazuya.inoue@ompu.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	2022 Year 05 Month 17 Day

Related information
URL releasing protocol
Publication of results	Partially published

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	2020 Year 06 Month 02 Day
Date of IRB	2020 Year 06 Month 02 Day
Anticipated trial start date	2020 Year 08 Month 06 Day
Last follow-up date	2025 Year 05 Month 11 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 05 Month 17 Day
Last modified on	2022 Year 05 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000054467