Ireland
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Recruiting Observational

Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

NCT05339789 · tracked via the Priya Life Science Sweden tracker
Phase
Observational
Started
2020-08-30
Last updated
2024-02-16

Condition(s) studied

Peri-Implantitis

Study 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

Sex
ALL
Min age
18 Years
Max age
130 Years
Healthy volunteers
No
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 outcome measure(s)

  • Disease resolution (Binary: yes/no) — 12 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 24 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 36 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 48 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 60 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 72 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 84 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 96 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 108 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.
  • Disease resolution (Binary: yes/no) — 120 months postoperative
    Disease resolution will be defined as peri-implant probing pocket depth ≤ 5 mm and no excessive bleeding and/or suppuration on probing.

Trial sites (3)

FacilityCityRegionStatus
Dental Clinic, Sigmund Freud University Vienna Vienna Austria Recruiting
Blekinge hospital Karlskrona Sweden Recruiting
Malmö University Malmö Sweden Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05339789 on ClinicalTrials.gov ↗ ← All trials in Sweden