Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study

Geistlich Pharma AG59 enrolled

Overview

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

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

Study Type

OBSERVATIONAL

Enrollment

Conditions

Peri-implantitis

Interventions

observational studyOTHER

Observational study

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Kristianstad University

Kristianstad, Sweden

Outcomes

Primary Outcomes

Defect fill

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

Time frame: 2 years after the start of the study

Data from ClinicalTrials.gov

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