Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study
- Conditions
- Peri-implantitis
- Registration Number
- NCT03776097
- Lead Sponsor
- Geistlich Pharma AG
- Brief Summary
The objective of this non-interventional long-term follow-up observation is to evaluate the long-term sustainability of two surgical treatments of peri-implantitis with and without Geistlich Bio-Oss® and Geistlich Bio-Gide® from a previous study
- Detailed Description
The study is a non-interventional long-term follow-up observation without any study specific procedure outside normal clinical routine. Patients from a previous study are selected to participate in this study within a standard maintenance Programm. Primary and secondary oucomes refer to the previous study
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 59
- Implant survival at the treated site from the previous study
- Written informed consent
- Implant failure at the treated site
- Severe trauma to implant site causing removal of the implant since the last visit of previous study
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Defect fill 2 years after the start of the study The primary outcome measure will be the change of "bone levels"(defect fill) over 2 years starting 1 year after surgical Intervention as assessed from intra-oral radiographs. In particular, the distances between the most apical implant to bone contact level and a characteristic reference point being the same for all sets of radiographs will be measured. The distance equal to three implant threads (known for the implant system) will be measured with a specific Software. The deeper bone level at baseline will be considered
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Kristianstad University
🇸🇪Kristianstad, Sweden
Kristianstad University🇸🇪Kristianstad, Sweden