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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016611
Receipt No. R000019233
Scientific Title A clinical study of dental implant treatment with nongrafted sinus lift using a computer guiding system
Date of disclosure of the study information 2015/02/26
Last modified on 2017/06/26

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Basic information
Public title A clinical study of dental implant treatment with nongrafted sinus lift
using a computer guiding system
Acronym Nongrafted sinus lift
using a computer guiding system
Scientific Title A clinical study of dental implant treatment with nongrafted sinus lift
using a computer guiding system
Scientific Title:Acronym Nongrafted sinus lift
using a computer guiding system
Region
Japan

Condition
Condition Missing teeth
Classification by specialty
Oral surgery
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate the safety and usefulness of nongrafted sinus lift using a computer guiding system.
Basic objectives2 Safety,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. Follow-up periods

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
Maneuver
Interventions/Control_1 Sinus lifting without graft materials through crestal approach using a computer guiding system.
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
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
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 None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor None
Name of secondary funder(s) None

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

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 26 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2014 Year 12 Month 25 Day
Date of IRB
Anticipated trial start date
2015 Year 02 Month 27 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
2017 Year 06 Month 26 Day
Date trial data considered complete
2017 Year 06 Month 26 Day
Date analysis concluded
2017 Year 06 Month 26 Day

Other
Other related information

Management information
Registered date
2015 Year 02 Month 23 Day
Last modified on
2017 Year 06 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019233

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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