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

Peri-implantitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03776097
• Other study ID #: 23530231
• Status: Completed
• Start date: December 2015
• Est. completion date: March 21, 2019

Study information

• Verified date: August 2019
• Source: Geistlich Pharma AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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 information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: March 21, 2019
• Est. primary completion date: March 21, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Peri-implantitis

Intervention

Other:
• observational study
Observational study

Locations

Country	Name	City	State
Sweden	Kristianstad University	Kristianstad

Sponsors (1)

Lead Sponsor	Collaborator
Geistlich Pharma AG

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2 years after the start of the study