UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A clinical study of dental implant treatment with nongrafted sinus lift using a computer guiding system
Title of the study (Brief title)	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	Takahiro Kaneko
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Oral and Maxillofacial Surgery
Address	1981 Kamoda, Kawagoe, Saitama 350-8550
TEL	049-228-3687
Email	t_kaneko@saitama-med.ac.jp

Public contact
Name of contact person	Takahiro Kaneko
Organization	Saitama Medical Center, Saitama Medical University
Division name	Department of Oral and Maxillofacial Surgery
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Partially published
URL releasing results
Results
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