UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028915 |
|---|---|
| Receipt number | 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 13:35:35 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
t_kaneko@saitama-med.ac.jp
Sponsor or person
Institute
Department of Oral and Maxillofacial Surgery
Saitama Medical Center, Saitama Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033076
