UMIN-CTR Clinical Trial

Basic information
Public title	Clinical study of bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement
Acronym	Nongrafted sinus lift using a PLLA mesh plate device
Scientific Title	Clinical study of bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement
Scientific Title:Acronym	Nongrafted sinus lift using a PLLA mesh plate device
Region	Japan

Condition
Condition	Tooth loss
Classification by specialty	Oral surgery Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of present study was to evaluate clinical and radiographic outcomes of a nongrafted sinus-lifting procedure using a PLLA mesh plate device in combination with placement of dental implants and also to investigate whether the application of mesh plate device in nongrafted sinus lift procedure contribute to the promotion of bone formation in the sinus.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Implant survival rate 2. Preoperative and postoperative alveolar crest height
Key secondary outcomes	1. Presence of Schneiderian membrane perforation 2. Patients demographics 3. Position and dimension of the implants 4. Complications 5. Marginal bone loss

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	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Maxillary sinus lift is performed by sinus membrane elevation using a bioresorbable unsintered hydroxyapatite combined with poly L-lactide (HA/PLLA) mesh plate device(Super FIXSORB-MX, TEIJIN MEDICAL TECHNOLOGIES Co., Ltd. Osaka, Japan)
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subjects are competent to consent, keep the rules of the study and are able to report self-condition. 2. Subjects who are judged eligible by the investigator in several series of medical check conducted prior to study. 3. Patient must show atrophy in the posterior maxilla with healthy sinuses that are judged to need sinus augmentation procedure, but with residual alveolar crest height of 2 mm or greater.
Key exclusion criteria	1. Previous history of surgery and/or pathology in the maxillary sinuses. 2. Severe thickening of sinus membrane and pathology of neighboring teeth. 3. Subjects who are inadequate for enrollment judged by the investigator
Target sample size	15

Research contact person
Last name of lead principal investigator	1st name Middle name Last name Takahiro Kaneko
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Oral and Maxillofacial Surgery
Zip code
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3687
Email	t_kaneko@saitama-med.ac.jp

Public contact
1st name of contact person	1st name Middle name Last name Takahiro Kaneko
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Oral and Maxillofacial Surgery
Zip code
Address	1981 Kamoda, Kawagoe, Saitama 350-8550, Japan
TEL	049-228-3687
Homepage URL
Email	t_kaneko@saitama-med.ac.jp

Sponsor
Institute	Department of Oral and Maxillofacial Surgery Saitama Medical Center, Saitama Medical University
Institute
Department

Funding Source
Organization	TEIJIN MEDICAL TECHNOLOGES Co., LTD.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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	埼玉医科大学総合医療センター（埼玉県）

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 30 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
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	Completed
Date of protocol fixation	2017 Year 08 Month 30 Day
Date of IRB	2017 Year 11 Month 02 Day
Anticipated trial start date	2017 Year 11 Month 30 Day
Last follow-up date	2019 Year 03 Month 04 Day
Date of closure to data entry	2019 Year 03 Month 04 Day
Date trial data considered complete	2019 Year 03 Month 04 Day
Date analysis concluded	2019 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date	2017 Year 08 Month 30 Day
Last modified on	2019 Year 03 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000033076