Long-term Surgical Treatment Outcome of Peri-implantitis Lesions
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Peri-Implantitis. Basic parameters: 18 years — 130 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria, Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
The surgical treatment outcome of patients that have been or are consecutively treated at the University of Malmö, at Blekinge hospital, and at the Dental Clinic of the Sigmund Freud University Vienna will be evaluated on an a regular base; specifically all patients treated since 2014 and those receiving treatment in the future, will be regularly assessed, max. once per year after the 1-year control from the surgical intervention for clinical and radiographic assessment of healing. Clinical peri-implant parameters (e.g., probing pocket depth) and peri-implant sulcus fluid (PISF) are collected, and a peri-apical radiographic examination is made. Further, from 200 patients treated in the future, the inflammatory peri-implant lesion will be collected and subjected to histological, microbiological, and molecular analysis. The removal of these lesions is a standard procedure and performed in all patients independent of study participation; i.e., the lesion has anyway to be removed during surgery and if the lesions are not stored, they would be thrown.
Primary outcome measures
- Disease resolution (Binary: yes/no) [Time frame: 12 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 24 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 36 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 48 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 60 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 72 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 84 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 96 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 108 months postoperative]
- Disease resolution (Binary: yes/no) [Time frame: 120 months postoperative]
Eligibility criteria
Inclusion criteria
- All patients being treated since 2014 and continuously being treated will be called in for regular check-ups after the surgical intervention and an examination for study purpose will be performed annually.
Exclusion criteria
\- implant loss
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Sweden · 2 centers
- Blekinge hospital — Karlskrona
- Malmö University — Malmö
Austria · 1 center
- Dental Clinic, Sigmund Freud University Vienna — Vienna
Identifiers
NCT: NCT05339789 · 2020-01019