Implant Complication
Conditions
Brief summary
Observational study with one single arm. The purpose of this study was to evaluate the impact of the insertion torque and of the implant stability on the marginal bone level changes for dental implants placed into healed ridges.
Detailed description
The primary outcome would be to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform. The secondary outcomes would be: * To evaluate the Implant Stability Quotient (ISQ) changes according to the measurements performed with the instrument Penguin RFA * To evaluate the implant and prosthetic failure rate as well as the implant and prosthetic complication rates * The patient satisfaction related to the implant treatment
Interventions
DEVICEPenguin RFA
to evaluate the peri-implant bone level changes (marginal bone level) around the implant platform.
Sponsors
University of Geneva, Switzerland
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* All partially edentulous patients requiring simple Implant placement, * being at least 18-year-old and able to sign an informed consent, * The patients that will be enrolled must have a bone quantity that allows the placement of regular implants according to the radiographic evaluations (pre-operative radiographic examination).
Exclusion criteria
* Heavy smokers (more than 10 cigarettes/day). * Immunosuppressed or immunocompromised patients * Uncontrolled diabetes * Active periodontal disease * Patients with a full mouth marginal bleeding score higher than 20% * Addiction to alcohol or drugs * Psychiatric problems * Severe caries, periapical lesions, acute infection (abscess) * Immediate post-extractive implants (at least 2 months after extraction have to elapse) * Patients unable to commit to 3-year follow-up. * Patients treated or under treatment with intravenous amino- bisphosphonates. * Patients participating to other studies, if the present protocol could not be fully adhered to.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| radiographic marginal bone level changes around the implant platform | 3 years | the changes (in mm) of the marginal bone level around the implant platform |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Implant Stability Quotient (ISQ) changes | 3 years | the measurements will be performed with the instrument Penguin RFA |
Other
| Measure | Time frame | Description |
|---|---|---|
| implant complications rate | 3 years | % of implant complications |
| patient satisfaction related to the implant treatment | 3 years | degree of satisfaction on factors such as function, comfort and esthetics through questionnaires |
| implant failure rate | 3 years | % of implant failure |
| prosthetic complications rate | 3 years | % of prosthetic complications |
| prosthetic failure rate | 3 years | % of prosthetic failure |
Countries
Switzerland
Contacts
Primary ContactIrena Sailer, Prof. Dr.
Outcome results
None listed