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

NCT ID: NCT03776097

Last Updated: 2019-08-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

59 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-12-31

Study Completion Date

2019-03-21

Brief Summary

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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

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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

Conditions

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Peri-implantitis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Defect Fill.

Observational study of the patients that were treated with biomaterials at the surgery in the previous study

observational study

Intervention Type OTHER

Observational study

No defect Fill.observational

Observational study of the patients that were not treated with biomaterials at the surgery of te previous study

observational study

Intervention Type OTHER

Observational study

Interventions

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observational study

Observational study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Geistlich Pharma AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Silvia Rasi, PhD

Role: STUDY_DIRECTOR

Geistlich Pharma

Stefan Renvert

Role: PRINCIPAL_INVESTIGATOR

Kristianstadt University

Locations

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Kristianstad University

Kristianstad, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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23530231

Identifier Type: -

Identifier Source: org_study_id

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