UMIN-CTR Clinical Trial

Basic information
Public title	Long-term observation study for maxillary sinus floor augmentation using octa-calcium phosphate/collagen composite
Acronym	Long-term observation for maxillary sinus floor augmentation using OCP/collagen
Scientific Title	Long-term observation study for maxillary sinus floor augmentation using octa-calcium phosphate/collagen composite
Scientific Title:Acronym	Long-term observation for maxillary sinus floor augmentation using OCP/collagen
Region	Japan

Condition
Condition	alveolar bone atrophy
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Evaluation of dental implants newly formed bone 5 years after maxillary sinus floor augmentation using OCP/Col composite
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Dental implant status (infection, peri-implantitis, dental implant stability, pain, paresthesia) 5 years after maxillary sinus floor augmentation using OCP/Col composite
Key secondary outcomes	CT value (HU unit), vertical bone hight, new bone volume 5 years after maxillary sinus floor augmentation using OCP/Col composite

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	80 years-old >
Gender	Male and Female
Key inclusion criteria	Patients who were included in the clinical trial "a multi-center single arm clinical trial of bone regenerative material; OCP/Col"
Key exclusion criteria	Patients who are treated for bone metabolic diseases such as osteoporosis and who are taking bisphosphonate drugs
Target sample size	11

Research contact person
Name of lead principal investigator	1st name Izumi Middle name Last name Asahina
Organization	Nagasaki University Hospital
Division name	Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto , Nagasaki
TEL	095-819-7701
Email	asahina@nagasaki-u.ac.jp

Public contact
Name of contact person	1st name Izumi Middle name Last name Asahina
Organization	Nagasaki University Hospital
Division name	Oral Surgery
Zip code	852-8588
Address	1-7-1 Sakamoto , Nagasaki
TEL	095-819-7701
Homepage URL
Email	asahina@nagasaki-u.ac.jp

Sponsor
Institute	Nagasaki University Hospital
Institute
Department

Funding Source
Organization	Nagasaki University Hospital
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 Hospital
Address	1-7-1 Sakamoto , Nagasaki
Tel	095-819-7701
Email	asahina@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	2020 Year 09 Month 01 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	8
Results	The conditions of all dental implants were uneventful throughout the follow-up period. Augmented bone volume and changing rate of augmented bone volume were essentially unchanged following maturation of the OCP/Col-derived new bone. Mean marginal bone loss was 1.76 mm with the simultaneous approach, and 0.50 mm with the staged approach at five years postoperatively.
Results date posted	2022 Year 02 Month 22 Day
Results Delayed
Results Delay Reason	paper submitted
Date of the first journal publication of results
Baseline Characteristics	1. Individuals who had been included in the clinical trial entitled "A multi-center single arm clinical trial of bone regenerative material OCP/Col", which was registered as Trial No.UMIN000018192 and was conducted between 2015 and 2017; and who had received maxillary sinus floor augmentation via the lateral window approach at Nagasaki University Hospital. 2. Individuals aged between 20 and 79 years old at the time of providing consent.
Participant flow	8 out of 10 subjects were agreed to participate the study.
Adverse events	none
Outcome measures	The primary outcome was the evaluation of clinical dental implant conditions such as infection, peri-implantitis, dental implant stability, pain, and paresthesia. Secondary outcomes were the evaluation of the augmented bone volume, change rate of augmented bone volume, vertical bone height, and marginal bone loss around dental implant fixture.
Plan to share IPD	none
IPD sharing Plan description	none

Progress
Recruitment status	Enrolling by invitation
Date of protocol fixation	2020 Year 08 Month 17 Day
Date of IRB	2020 Year 08 Month 18 Day
Anticipated trial start date	2020 Year 09 Month 01 Day
Last follow-up date	2021 Year 07 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	Observation study of the clinical trial performed 5 years ago

Management information
Registered date	2020 Year 08 Month 19 Day
Last modified on	2022 Year 02 Month 22 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000047113