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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028915
Receipt No. R000033076
Scientific Title Clinical study of bone regeneration after nongrafted sinus lift with a PLLA mesh plate device and dental implant placement
Date of disclosure of the study information 2017/08/30
Last modified on 2019/03/13

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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
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
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/ctr_e/ctr_view.cgi?recptno=R000033076

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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