Single tooth gaps in the Anterior of Maxilla and Mandible including premolars
Conditions
Interventions
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 pr
Sponsors
Kyushu University Faculty of Dental Science
Eligibility
Sex/Gender
All
Inclusion criteria
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.
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radiographic assessment of crestal bone level change at the implant site between implant placement and 12 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 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) | — |
Countries
Japan
Contacts
Public ContactHirohide Koori
Kyushu University Faculty of Dental Science Department of Removable Prosthodontics
Outcome results
None listed