Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

NCT ID: NCT05339789

Last Updated: 2024-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-30

Study Completion Date

2030-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Peri-Implantitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

130 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Medical University of Vienna

OTHER

Sponsor Role collaborator

Sigmund Freud PrivatUniversitat

OTHER

Sponsor Role collaborator

Blekinge County Council Hospital

OTHER

Sponsor Role collaborator

Malmö University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kristina Bertl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Dental Clinic, Sigmund Freud University Vienna

Vienna, , Austria

Site Status RECRUITING

Blekinge hospital

Karlskrona, , Sweden

Site Status RECRUITING

Malmö University

Malmo, , Sweden

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Austria Sweden

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Kristina Bertl

Role: primary

00436645151194

Kristina Bertl

Role: primary

00436645151194

Kristina Bertl

Role: primary

00436645151194

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2020-01019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.