RecruitingNot ApplicableNCT06679283

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

Surgical Treatment of Peri-implantitis With Adjunctive Application of Platelet Rich Fibrin (PRF) Compared With Open Flap Debridement (OFD) Alone: A 12-month Randomised Clinical Trial


Sponsor

University of Bern

Enrollment

40 participants

Start Date

Feb 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • One or more peri-implant sites with PPD ≧ 5 mm combined with BOP/suppuration and
  • Peri-implant marginal bone loss, defined as a crater like defect ≧ 3 mm as assessed from intraoral radiographs
  • Good oral hygiene i.e. a plaque index <20%
  • Written informed consent

Exclusion Criteria7

  • History of chronic inflammatory disease
  • Severe systemic diseases
  • Medically confirmed diagnosis of diabetes mellitus
  • Anti-inflammatory prescription including prednisone
  • Smoking > 5 cigarettes
  • Pregnant or lactating women
  • < 18 years of age

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Interventions

PROCEDUREOpen flap debridement with a chemo-electric device + PRF

The defects will be removed from granulation tissue. Debridement by a chemical-electrical principle will be performed followed by application of PRF clots and membrane. Then, the flap will be closed and sutured.

PROCEDUREOpen flap debridement with a chemo-electric device alone (control)

The defects will be removed from granulation tissue. Debridement by a chemical-electrical principle will be performed. Then the flap will be closed and sutured.


Locations(1)

Department of Periodontology, University of Bern

Bern, Switzerland

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NCT06679283


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