NCT05339789

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
650

participants targeted

Target at P75+ for all trials

Timeline
57mo left

Started Aug 2020

Longer than P75 for all trials

Geographic Reach
2 countries

3 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress55%
Aug 2020Dec 2030

Study Start

First participant enrolled

August 30, 2020

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 11, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 21, 2022

Completed
8.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2030

Last Updated

February 16, 2024

Status Verified

February 1, 2024

Enrollment Period

10.3 years

First QC Date

April 11, 2022

Last Update Submit

February 15, 2024

Conditions

Peri-Implantitis

Outcome Measures

Primary Outcomes (10)

  • 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

Eligibility Criteria

Age18 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • \- implant loss

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Dental Clinic, Sigmund Freud University Vienna

Vienna, Austria

RECRUITING

Blekinge hospital

Karlskrona, Sweden

RECRUITING

Malmö University

Malmo, Sweden

RECRUITING

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 11, 2022

First Posted

April 21, 2022

Study Start

August 30, 2020

Primary Completion (Estimated)

December 31, 2030

Study Completion (Estimated)

December 31, 2030

Last Updated

February 16, 2024

Record last verified: 2024-02

Locations

AU(1)SE(2)