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Surgical Treatment of Peri-implantitis With Adjunctive Application of Platelet Rich Fibrin (PRF)

Study acronym: PRF
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Minor Re-verified, no change to tracked fieldsv4
  2. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Feb 10, 2025 to Feb 1, 2025
    • Study description shortened, about 189 words
    • Site details revised
    v3
  3. Minor Study description shortened, about 78 wordsv2
  4. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Platelet-rich fibrin (PRF) is a second-generation platelet concentrate used for tissue and bone regeneration. PRF releases growth factors such as TGF-β, PDGF, VEGF, IGF, and FGF, which are known to promote wound healing and bone regeneration. Thus, PRF may offer a promising therapeutic approach for peri-implantitis treatment. Numerous studies have reported beneficial effects of PRF on bone regeneration, bone augmentation, soft tissue healing, and ridge preservation. In infrabony periodontal defects, PRF has shown significant improvements in pocket depth reduction, clinical attachment level (CAL) gain, and bone fill. However, a recent systematic review highlighted that evidence supporting PRF use in peri-implantitis remains limited, primarily due to a lack of adequately designed studies. Therefore, the aim of this project is to investigate whether PRF enhances regeneration in peri-implantitis defects. Specifically, it will assess whether surgical debridement of peri-implantitis defects-including electrochemical detoxification of implant surfaces using GalvoSurge-combined with PRF clot and membrane placement, improves treatment outcomes compared to surgical debridement and detoxification using GalvoSurge alone. For this purpose, implants with peri-implantitis defects of comparable size will be randomly assigned to either the test or control group. After 12 months, implants will be clinically evaluated for radiographic defect fill, reduction in probing pocket depth (PPD), and bleeding on probing (BOP). The objective of this project is to verify, both radiographically and clinically, whether adjunctive PRF application enhances tissue regeneration and healing of peri-implantitis defects compared to open flap debridement (OFD) alone.
Trial Details
NCT Number NCT06679283
Lead Sponsor University of Bern
Conditions
(from sponsor)
Peri-Implantitis, Bone Resorption, Platelet-Rich Fibrin
Related terms Bone Resorption, Peri-Implantitis
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov