Surgical Treatment of Peri-implantitis With Adjunctive Application of Platelet Rich Fibrin (PRF)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
History of chronic inflammatory disease
Severe systemic diseases
Medically confirmed diagnosis of diabetes mellitus
Anti-inflammatory prescription including prednisone
Trial design
Design model
Parallel
Treatments tested in this trial
Open flap debridement with a chemo-electric device + PRF
Procedure/SurgeryThe 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.
Open flap debridement with a chemo-electric device alone (control)
Procedure/SurgeryThe defects will be removed from granulation tissue. Debridement by a chemical-electrical principle will be performed. Then the flap will be closed and sutured.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Open flap debridement with a chemo-electric device + PRFExperimental treatment 1 intervention
Group B: Open flap debridement with a chemo-electric device aloneActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Radiographic defect fill after 12 months
Radiographs of the implant will be made 12 months after the intervention and compared to baseline radiographs. Defect fill in mm will be assessed.
Time frame
Baseline, 12-month follow-upSecondary outcomes
1
Change of probing pocket depth
Probing pocket depth (PPD) around the implants will be assessed at baseline and after 12 months after the intervention. PPD will be measured as the distance from the mucosal margin to the bottom of the peri-implant pocket using a periodontal probe with mm markings.
Time frame
Baseline, 12-month follow-up2
Change in bleeding on probing
Bleeding on probing with 20 Ncm will be assessed at 6 sites around the implant at baseline and after 6 months. Bleeding on probing reflects the inflammatory state of the peri-implant tissues. Healthy peri-implant tissues present with no bleeding upon gentle probing. According to the grade of inflammation more sites around the implant bleed upon probing. 6 sites per implant will be assessed: mesiobuccal, midbuccal, distobuccal, distolingual, midlingual, mesiolingual. Change in the number of bleeding spots will be assessed from baseline to the 12-month follow-up.
Time frame
Baseline, 12-month follow-up3
Soft tissue healing
Healing during the first 2 weeks will be assessed by the early wound healing index. It is represented by a scale. When a low number on the scale is given, fast and uneventful healing occurs.
Time frame
2 days post-surgery, 7 days and 14 days post-surgery4
Radiographic and clinical composite index
A composite outcome of no evidence of BoP (one site out of 6 will be accepted), with no suppuration at any site, PPD ≤ 5 mm and with ≥1 mm defect fill will be used for a successful outcome.
Time frame
Baseline, 12-month follow-upSponsors and contacts
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Source ClinicalTrials.gov