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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000009319
Receipt No. R000010944
Scientific Title Evaluation of the performance of Straumann Bone Level Implant with SLA surface in Single Tooth Gaps in the Anterior and Premolar of Maxilla and Mandible.
Date of disclosure of the study information 2012/11/12
Last modified on 2014/03/06

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Basic information
Public title Evaluation of the performance of Straumann Bone Level Implant
with SLA surface in Single Tooth Gaps
in the Anterior and Premolar of Maxilla and Mandible.
Acronym Evaluation of the performance of Straumann Bone Level Implant
Scientific Title Evaluation of the performance of Straumann Bone Level Implant
with SLA surface in Single Tooth Gaps
in the Anterior and Premolar of Maxilla and Mandible.
Scientific Title:Acronym Evaluation of the performance of Straumann Bone Level Implant
Region
Japan

Condition
Condition Single tooth gaps in the Anterior of Maxilla and Mandible including premolars
Classification by specialty
Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 An MCT cohort study to evaluate the performance of Straumann Bone Level (BL) Implant with SLA surface in single tooth gaps in the Anterior of Maxilla and Mandible including premolars with immediate provisionalisation
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Radiographic assessment of crestal bone level change at the implant site between implant placement and 12 months
Key secondary outcomes Radiographic assessment of crestal bone level change
Evaluation of implant success
Evaluation of implant survival
Pink Esthetic Score (PES)/White Esthetic Score (WES) 2)
2)WES: If at all possible.
VAS (Visual Analog Scale) to examine subject satisfaction about esthetic restoration
Evaluation of soft tissue recession
Measurement of PPD and CAL
Resonance frequency analysis (RFA)

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 An MCT cohort study to evaluate the performance of Straumann Bone Level (BL) Implant with SLA surface in single tooth gaps in the Anterior of Maxilla and Mandible including premolars with immediate provisionalisation
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Subjects with a single missing tooth in the maxillary and mandible esthetic zone (anterior and premolar areas)
Subjects with natural or restored mesial and distal adjacent teeth to the missing tooth. The condition of the adjacent teeth will not change during this study.
Subjects with opposing dentition to the single missing tooth to be treated.
Subjects with O Leary s Plaque Control score of <25% at screening.
Subjects with sufficient bone mass in the implant placement site and Type I to III of bone quality.
Subjects who underwent an autogenous bone grafting for esthetic purposes 3 months prior to the dental implant surgery (Subjects are eligible if the grafting were conducted 3 months prior to the dental implant surgery and the bone was grafted at the site where the implant thread may slightly (within 2 to 3 mm) be exposed from bone in a facial direction if the implant is placed 3 mm lower than the facial CEJ (Cement-Enamel Junction)of the adjacent teeth.).
Subjects who commit to the follow-up visits in the study.
Subjects who sign consent forms to show their agreement to take part in the study
Subjects (male and female) aged 20 years or older.
Key exclusion criteria 1.Subjects with a systemic disease that may affect the implant treatment.
2.Subjects with any of the following diseases that is contraindicated or relatively contraindicated in oral surgical treatment disorders
3.Subjects with tooth root at planned implantation.
4.Subjects with an untreated tooth that needs endodontic care in an adjacent part of the implant placement site.
5.Subjects with a 4-mm or deeper periodontal pocket in an adjacent tooth of the implant placement site.
6.Subjects with severe habits of bruxism or clenching.
7.Subjects who smoke more than 10 cigarettes a day or subjects who cannot stop smoking for 2 weeks before and after the implant placement surgery.
8.Subjects who plan to participate in other clinical trial, or investigation 30 days prior to or during this study.
9.Subjects who are pregnant or nursing or subjects who plan to be pregnant during this study.
10.Subjects who cannot understand this study or subjects that the investigator deems ineligible to participate in this study.
11.Subjects who need sinus lift.
12.Subjects with a history of failure of implant placement in the site where an implant is planned to be placed in this study.
13.Subjects within 12 weeks of tooth extraction.
Target sample size 48

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kiyoshi Koyano
Organization Kyushu University Faculty of Dental Science
Division name Implant and Rehabilitative Dentistry
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL 092-642-6376
Email koyano@dent.kyushu-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirohide Koori
Organization Kyushu University Faculty of Dental Science
Division name Department of Removable Prosthodontics
Zip code
Address 3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
TEL 092-642-6441
Homepage URL
Email hkoori@dent.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Faculty of Dental Science
Institute
Department

Funding Source
Organization Straumann Japan K.K
Organization
Division
Category of Funding Organization Outside Japan
Nationality of Funding Organization SWITZERLAND

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

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 12 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 No longer recruiting
Date of protocol fixation
2011 Year 12 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 02 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2012 Year 11 Month 12 Day
Last modified on
2014 Year 03 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010944

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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