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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000047778
Receipt No. R000054467
Scientific Title Clinical study of dental implant treatment for patients taking bone resorption inhibitors and angiogenesis inhibitors
Date of disclosure of the study information 2022/05/17
Last modified on 2022/05/17

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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

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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