UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009319
Receipt number 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 14:09:29

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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 or person

Institute

Kyushu University Faculty of Dental Science

Institute

Department

Personal name



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

Value
https://center6.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