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

Completed

• Conditions: Peri-implantitis
• Interventions: Other: observational study

• 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

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2016-08-08
• Study First Submitted QC: 2018-12-13
• Study First Posted: 2018-12-14
• Primary Completion: 2019-03-21
• Study Completion: 2019-03-21
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-23
• Last Update Posted: 2019-08-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Defect Fill.	observational study	Observational study of the patients that were treated with biomaterials at the surgery in the previous study
No defect Fill.observational	observational study	Observational study of the patients that were not treated with biomaterials at the surgery of te previous study

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

Trial Locations

Locations (1)

Kristianstad University; 🇸🇪 Kristianstad, Sweden