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NCT Number: NCT05339789

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.

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Key information

Conditions

Peri-implantitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

18 year–130 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Dental Clinic, Sigmund Freud University Vienna, Vienna, Austria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Disease resolution (Binary: yes/no)

    Time frame: 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.

  2. Disease resolution (Binary: yes/no)

    Time frame: 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.

  3. Disease resolution (Binary: yes/no)

    Time frame: 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.

  4. Disease resolution (Binary: yes/no)

    Time frame: 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.

  5. Disease resolution (Binary: yes/no)

    Time frame: 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.

  6. Disease resolution (Binary: yes/no)

    Time frame: 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.

  7. Disease resolution (Binary: yes/no)

    Time frame: 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.

  8. Disease resolution (Binary: yes/no)

    Time frame: 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.

  9. Disease resolution (Binary: yes/no)

    Time frame: 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.

  10. Disease resolution (Binary: yes/no)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Malmö University

Other

Collaborators

  • Blekinge County Council Hospital
  • Medical University of Vienna
  • Sigmund Freud PrivatUniversitat

Registry information

Important dates

Study start
2020
Primary completion
2030
Study completion
2030
First posted
Apr 21, 2022
Registry last updated
Feb 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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