UMIN-CTR Clinical Trial

Basic information
Public title	The long term assessment of the augmented bone by the sinus floor augmentation.
Acronym	The long term assessment of the augmented bone by the sinus floor augmentation.
Scientific Title	The long term assessment of the augmented bone by the sinus floor augmentation.
Scientific Title:Acronym	The long term assessment of the augmented bone by the sinus floor augmentation.
Region	Japan

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

Objectives
Narrative objectives1	To assess the decreasing rate of the augmented bone after the sinus floor augmentation with various materials.
Basic objectives2	Others
Basic objectives -Others	the change of the shape of the graft material.
Trial characteristics_1	Confirmatory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	the amount of the change of the augmented bone after the sinus floor augmentation.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	Tapient who underwent the dental implant treatment after the sinus floor augmentation.
Key exclusion criteria	taking BP drug or anti-RANKL monoclonal drug.
Target sample size	32

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Regenerative Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7704
Email	sohba@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Regenerative Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto, Nagasaki
TEL	095-819-7704
Homepage URL
Email	sohba@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University
Institute
Department

Funding Source
Organization	Nagasaki 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	Nagasaki University
Address	1-7-1 Sakamoto, Nagasaki
Tel	095-819-7704
Email	sohba@nagasaki-u.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	2019 Year 11 Month 14 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	12
Results	Augmented bone volume tended to be decreased by the angle between the lateral and medial bone of the maxillary sinus floor.
Results date posted	2021 Year 11 Month 25 Day
Results Delayed	Delay expected
Results Delay Reason	now writing.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events	none
Outcome measures	bone volume.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2019 Year 11 Month 14 Day
Date of IRB	2019 Year 12 Month 18 Day
Anticipated trial start date	2020 Year 01 Month 01 Day
Last follow-up date	2020 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	now writing the article. finalizing.

Management information
Registered date	2019 Year 11 Month 14 Day
Last modified on	2022 Year 11 Month 16 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000043978