Unique ID issued by UMIN | UMIN000009319 |
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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 |
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.
Evaluation of the performance of Straumann Bone Level Implant
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.
Evaluation of the performance of Straumann Bone Level Implant
Japan |
Single tooth gaps in the Anterior of Maxilla and Mandible including premolars
Dental medicine | Adult |
Others
NO
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
Efficacy
Radiographic assessment of crestal bone level change at the implant site between implant placement and 12 months
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)
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Device,equipment |
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
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
48
1st name | |
Middle name | |
Last name | Kiyoshi Koyano |
Kyushu University Faculty of Dental Science
Implant and Rehabilitative Dentistry
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
092-642-6376
koyano@dent.kyushu-u.ac.jp
1st name | |
Middle name | |
Last name | Hirohide Koori |
Kyushu University Faculty of Dental Science
Department of Removable Prosthodontics
3-1-1 Maidashi Higashi-ku Fukuoka 812-8582, Japan
092-642-6441
hkoori@dent.kyushu-u.ac.jp
Kyushu University Faculty of Dental Science
Straumann Japan K.K
Outside Japan
SWITZERLAND
NO
2012 | Year | 11 | Month | 12 | Day |
Unpublished
No longer recruiting
2011 | Year | 12 | Month | 12 | Day |
2012 | Year | 02 | Month | 20 | Day |
2012 | Year | 11 | Month | 12 | Day |
2014 | Year | 03 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010944
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