Non-interventional Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Follow-up (PMCF) Study 13.530.231
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Peri-implantitis
- Sponsor
- Geistlich Pharma AG
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Defect fill
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Implant survival at the treated site from the previous study
- •Written informed consent
Exclusion Criteria
- •Implant failure at the treated site
- •Severe trauma to implant site causing removal of the implant since the last visit of previous study
Outcomes
Primary Outcomes
Defect fill
Time Frame: 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