Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study
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
1 other identifier
observational
59
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2015
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 8, 2016
CompletedFirst Posted
Study publicly available on registry
December 14, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 21, 2019
CompletedAugust 28, 2019
August 1, 2019
3.3 years
August 8, 2016
August 23, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Defect Fill.
Observational study of the patients that were treated with biomaterials at the surgery in the previous study
No defect Fill.observational
Observational study of the patients that were not treated with biomaterials at the surgery of te previous study
Interventions
Eligibility Criteria
patients from a previous study
You may qualify if:
- Implant survival at the treated site from the previous study
- Written informed consent
You may not qualify if:
- Implant failure at the treated site
- Severe trauma to implant site causing removal of the implant since the last visit of previous study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kristianstad University
Kristianstad, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Silvia Rasi, PhD
Geistlich Pharma
- PRINCIPAL INVESTIGATOR
Stefan Renvert
Kristianstadt University
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 8, 2016
First Posted
December 14, 2018
Study Start
December 1, 2015
Primary Completion
March 21, 2019
Study Completion
March 21, 2019
Last Updated
August 28, 2019
Record last verified: 2019-08