UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of sinus floor augmentation by hydroxyapatite/collagen composite material
Acronym	Sinus floor augmentation by HAp/Col
Scientific Title	Clinical study of sinus floor augmentation by hydroxyapatite/collagen composite material
Scientific Title:Acronym	Sinus floor augmentation by HAp/Col
Region	Japan

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

Objectives
Narrative objectives1	To assess bone negeneration for sinus flooraugmentation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	ISQ 6 months after implantation.
Key secondary outcomes	1. new bone formation.

Base
Study type	Others,meta-analysis etc

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	18 years-old <=
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	Patient who needs sinus floor augmentation for dental implantation.
Key exclusion criteria	1. uncontrolled DM 2. severe renal and hepatic disorders.
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Seigo Middle name Last name Ohba
Organization	Nagasaki University
Division name	Division of 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	Division of 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	2017 Year 05 Month 31 Day

Related information
URL releasing protocol	https://www.jstage.jst.go.jp/article/josnusd/63/3/63_21-0163/_article/-char/ja/
Publication of results	Unpublished

Result
URL related to results and publications	https://www.jstage.jst.go.jp/article/josnusd/63/3/63_21-0163/_article/-char/ja/
Number of participants that the trial has enrolled	11
Results	This material induces the new bone formation in the maxillary sinus. On the other hand, some implants could not acquire the osseointegration when the original bone volume was insufficient.
Results date posted	2021 Year 11 Month 18 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics	Nineteen implants were placed into 14 maxillary sinuses.
Participant flow	Two implants were placed in 2 maxillary sinuses via the crestal approach, and 17 implants (OsseoSpeed; 10 implants, Finesia; 1 implant, Straumann; 6 implants) were placed in 12 maxillary sinuses via the lateral approach.
Adverse events	Three implants were lost.
Outcome measures	The alveolar bone height and cortical bone thickness of the alveo- lar bone ridge (cortical bone thickness) at the implant placement positions were measured on preoperative CBCT (3D Accuitomo F17D, Morita, Kyoto, Japan) images.　Insertion torque and ISQ were also measured.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 11 Month 05 Day
Date of IRB	2015 Year 11 Month 05 Day
Anticipated trial start date	2015 Year 11 Month 05 Day
Last follow-up date	2019 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	presentation at the annual meeting of Japanese association of oral implanvology in 23018. Stop the exam.

Management information
Registered date	2017 Year 05 Month 31 Day
Last modified on	2021 Year 11 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031606