Peri-implantitisNCT03776097
Long-term Follow-up Observation After Surgical Treatment of Peri-implantitis in Multicenter Post Market Clinical Study
An observational study of Peri-implantitis, run by Geistlich Pharma AG at 1 site in Sweden.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peri-implantitis
- What is being tested?
- observational study
- How many people
- 59 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2015to 21 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients from a previous study
Who may be able to join
- Implant survival at the treated site from the previous study
- Written informed consent
Who cannot join
- Implant failure at the treated site
- Severe trauma to implant site causing removal of the implant since the last visit of previous study
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Peri-implantitis
- Being tested
- observational study
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
Observational study
| Study group | Role | What they receive |
|---|---|---|
| Defect Fill. | Observational study of the patients that were treated with biomaterials at the surgery in the previous study Receives: 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 Receives: Other: observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years after the start of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2018
- Study startDec 2015
- Primary completion21 Mar 2019
- Study completion21 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peri-implantitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- Geistlich Pharma AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Silvia Rasi, PhD, Study director, Geistlich PharmaStefan Renvert, Principal investigator, Kristianstadt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776097
- Sponsor's protocol ID
- 23530231
- Status last verified
- Aug 2019
- First submitted
- 8 Aug 2016
- Last updated
- 28 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03776097
- Acronym / sponsor ID
- 23530231
- Conditions
- Peri-implantitis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- Geistlich Pharma AGIndustry (pharma, biotech, devices)
- Study start
- Dec 2015
- Primary completion
- 21 Mar 2019 (actual)
- Study completion
- 21 Mar 2019 (actual)
- First posted
- 14 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Defect Fill. | – | Other: observational studyObservational study of the patients that were treated with biomaterials at the surgery in the previous study |
| No defect Fill.observational | – | Other: observational studyObservational study of the patients that were not treated with biomaterials at the surgery of te previous study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients from a previous study
Key inclusion criteria (2 listed)
- Implant survival at the treated site from the previous study
- Written informed consent
Key exclusion criteria (2 listed)
- Implant failure at the treated site
- Severe trauma to implant site causing removal of the implant since the last visit of previous study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational studyObservational study | Other | Defect Fill., No defect Fill.observational |
Primary outcome
Defect fill
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Silvia Rasi, PhD study director
Geistlich Pharma
Stefan Renvert principal investigator
Kristianstadt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peri-implantitis, run by Geistlich Pharma AG at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Defect fill (time frame: 2 years after the start of the study). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.