Clinical trial NCT05339789: Long-term Surgical Treatment Outcome of Peri-implantitis Lesions
Official title: Long-term Surgical Treatment Outcome of Peri-implantitis Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Peri-Implantitis
Lead sponsor: Malmö University
Sponsor class: OTHER
Collaborators: name: Medical University of Vienna
name: Sigmund Freud PrivatUniversitat
name: Blekinge County Council Hospital
First posted: 2022-04-21
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Maximum age (years): 130
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


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

Primary outcomes:
measure: Disease resolution (Binary: yes/no)
timeFrame: 12 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 24 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 36 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 48 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 60 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 72 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 84 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 96 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 108 months postoperative
measure: Disease resolution (Binary: yes/no)
timeFrame: 120 months postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Dental Clinic, Sigmund Freud University Vienna
city: Karlskrona
country: Sweden
facility: Blekinge hospital
city: Malmö
country: Sweden
facility: Malmö University
Study officials:
References: