Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

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.

Study Overview

• Status: Recruiting
• Conditions: Peri-Implantitis

• Study Type: Observational
• Enrollment (Estimated): 650

Contacts and Locations

Study Locations

• Austria
  • Vienna, Austria
    • Recruiting
    • Dental Clinic, Sigmund Freud University Vienna
    • Contact: Kristina Bertl; Phone Number: 00436645151194; Email: kristina.bertl@med.sfu.ac.at
• Sweden
  • Karlskrona, Sweden
    • Recruiting
    • Blekinge Hospital
    • Contact: Kristina Bertl; Phone Number: 00436645151194; Email: kristina.bertl@regionblekinge.se
  • Malmö, Sweden
    • Recruiting
    • Malmö University
    • Contact: Kristina Bertl; Phone Number: 00436645151194; Email: kristina.bertl@mau.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 130 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Malmö University
• Collaborators: Medical University of Vienna; Blekinge County Council Hospital; Sigmund Freud PrivatUniversitat

Study record dates

Study Major Dates

• Study Start (Actual): August 30, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: April 11, 2022
• First Submitted That Met QC Criteria: April 15, 2022
• First Posted (Actual): April 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 15, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Peri-Implantitis
• Other Study ID Numbers: 2020-01019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No