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Long-term Surgical Treatment Outcome of Peri-implantitis Lesions

StatusRecruiting
PhaseNot specified
Started
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Record History

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  1. Enrollment target: 300 to 650v4 Show 4 more changesShow less
    • Primary and study completion dates: Dec 31, 2023 to Dec 31, 2030
    • Study sites: 1 to 3
    • Collaborators: 1 to 3
    • Eligibility criteria shortened, about 5 words
  2. Primary completion date: Apr 30, 2023 to Dec 31, 2023v3
  3. Primary completion date: Dec 31, 2022 to Apr 30, 2023v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 Details
NCT Number NCT05339789
Lead Sponsor Malmö University
Collaborators: Medical University of Vienna, Sigmund Freud PrivatUniversitat, Blekinge County Council Hospital
Conditions
(from sponsor)		 Peri-Implantitis
Related terms Peri-Implantitis
Enrollment 650 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov