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

Sponsor
Geistlich Pharma AG (Industry)
Overall Status
Completed
CT.gov ID
NCT03776097
Collaborator
(none)
59
Enrollment
1
Location
39.6
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Other: observational 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 Design

Study Type:
Observational
Actual Enrollment :
59 participants
Observational Model:
Other
Time Perspective:
Prospective
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
Study Start Date :
Dec 1, 2015
Actual Primary Completion Date :
Mar 21, 2019
Actual Study Completion Date :
Mar 21, 2019

Arms and Interventions

Arm Intervention/Treatment
Defect Fill.

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

Other: observational study
Observational study
No defect Fill.observational

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

Other: observational study
Observational study

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Kristianstad University Kristianstad Sweden

Sponsors and Collaborators

  • Geistlich Pharma AG

Investigators

  • Study Director: Silvia Rasi, PhD, Geistlich Pharma
  • Principal Investigator: Stefan Renvert, Kristianstadt University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Geistlich Pharma AG
ClinicalTrials.gov Identifier:
NCT03776097
Other Study ID Numbers:
  • 23530231
First Posted:
Dec 14, 2018
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:
Peri-Implantitis

Study Results

No Results Posted as of Aug 28, 2019