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

NCT06679283 | Recruiting DMC

• 1 other identifier: PRF
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Peri-Implantitis; Bone Resorption; Platelet-Rich Fibrin

Keywords

platelet rich fibrin, peri-implantitis

Outcome Measures

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.

  Baseline, 12-month follow-up

Secondary Outcomes (6)

• Change of probing pocket depth

  Baseline, 12-month follow-up

• Change in bleeding on probing

  Baseline, 12-month follow-up

• Soft tissue healing

  2 days post-surgery, 7 days and 14 days post-surgery

• Radiographic and clinical composite index

  Baseline, 12-month follow-up

• Patient-reported outcome pain assessed by visual analogue scale (VAS)

  2 days post-surgery, 7 days and 14 days post-surgery

Study Arms (2)

Open flap debridement with a chemo-electric device + PRF

EXPERIMENTAL

A mucoperiosteal flap will be raised to visualize the peri-implant defect, granulation tissue will be removed and the implant surface will be cleaned with a chemo-electric device. Thereafter venous blood will be taken, PRF clots and membranes will be prepared after blood centrifugation. The clots and membrane will be applied into the defect. Finally the flap is closed.

Procedure: Open flap debridement with a chemo-electric device + PRF

Open flap debridement with a chemo-electric device alone

ACTIVE COMPARATOR

A mucoperiosteal flap will be raised to visualize the peri-implant defect, granulation tissue will be removed and the implant surface will be cleaned with a chemo-electric device. Thereafter the flap is closed.

Procedure: Open flap debridement with a chemo-electric device alone (control)

Interventions

Open flap debridement with a chemo-electric device + PRF PROCEDURE

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.

Open flap debridement with a chemo-electric device + PRF

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

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.

Open flap debridement with a chemo-electric device alone

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: A balanced randomisation is being performed.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

RECRUITING

Related Publications (11)

• Berglundh T, Armitage G, Araujo MG, Avila-Ortiz G, Blanco J, Camargo PM, Chen S, Cochran D, Derks J, Figuero E, Hammerle CHF, Heitz-Mayfield LJA, Huynh-Ba G, Iacono V, Koo KT, Lambert F, McCauley L, Quirynen M, Renvert S, Salvi GE, Schwarz F, Tarnow D, Tomasi C, Wang HL, Zitzmann N. Peri-implant diseases and conditions: Consensus report of workgroup 4 of the 2017 World Workshop on the Classification of Periodontal and Peri-Implant Diseases and Conditions. J Clin Periodontol. 2018 Jun;45 Suppl 20:S286-S291. doi: 10.1111/jcpe.12957.

  PMID: 29926491 BACKGROUND

• Bosshardt DD, Brodbeck UR, Rathe F, Stumpf T, Imber JC, Weigl P, Schlee M. Evidence of re-osseointegration after electrolytic cleaning and regenerative therapy of peri-implantitis in humans: a case report with four implants. Clin Oral Investig. 2022 Apr;26(4):3735-3746. doi: 10.1007/s00784-021-04345-1. Epub 2022 Mar 4.

  PMID: 35244779 BACKGROUND

• Berglundh T, Lindhe J, Marinello C, Ericsson I, Liljenberg B. Soft tissue reaction to de novo plaque formation on implants and teeth. An experimental study in the dog. Clin Oral Implants Res. 1992 Mar;3(1):1-8. doi: 10.1034/j.1600-0501.1992.030101.x.

  PMID: 1420721 BACKGROUND

• Derks J, Tomasi C. Peri-implant health and disease. A systematic review of current epidemiology. J Clin Periodontol. 2015 Apr;42 Suppl 16:S158-71. doi: 10.1111/jcpe.12334.

  PMID: 25495683 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part III: leucocyte activation: a new feature for platelet concentrates? Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e51-5. doi: 10.1016/j.tripleo.2005.07.010.

  PMID: 16504851 BACKGROUND

• Roccuzzo M, Layton DM, Roccuzzo A, Heitz-Mayfield LJ. Clinical outcomes of peri-implantitis treatment and supportive care: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:331-350. doi: 10.1111/clr.13287.

  PMID: 30328195 BACKGROUND

• Lang NP, Bragger U, Walther D, Beamer B, Kornman KS. Ligature-induced peri-implant infection in cynomolgus monkeys. I. Clinical and radiographic findings. Clin Oral Implants Res. 1993 Mar;4(1):2-11. doi: 10.1034/j.1600-0501.1993.040101.x.

  PMID: 8329533 BACKGROUND

• Miron RJ, Zucchelli G, Pikos MA, Salama M, Lee S, Guillemette V, Fujioka-Kobayashi M, Bishara M, Zhang Y, Wang HL, Chandad F, Nacopoulos C, Simonpieri A, Aalam AA, Felice P, Sammartino G, Ghanaati S, Hernandez MA, Choukroun J. Use of platelet-rich fibrin in regenerative dentistry: a systematic review. Clin Oral Investig. 2017 Jul;21(6):1913-1927. doi: 10.1007/s00784-017-2133-z. Epub 2017 May 27.

  PMID: 28551729 BACKGROUND

• Pontoriero R, Tonelli MP, Carnevale G, Mombelli A, Nyman SR, Lang NP. Experimentally induced peri-implant mucositis. A clinical study in humans. Clin Oral Implants Res. 1994 Dec;5(4):254-9. doi: 10.1034/j.1600-0501.1994.050409.x.

  PMID: 7640340 BACKGROUND

• Pradeep AR, Karvekar S, Nagpal K, Patnaik K, Raju A, Singh P. Rosuvastatin 1.2 mg In Situ Gel Combined With 1:1 Mixture of Autologous Platelet-Rich Fibrin and Porous Hydroxyapatite Bone Graft in Surgical Treatment of Mandibular Class II Furcation Defects: A Randomized Clinical Control Trial. J Periodontol. 2016 Jan;87(1):5-13. doi: 10.1902/jop.2015.150131. Epub 2015 Oct 5.

  PMID: 26439386 BACKGROUND

• Hamzacebi B, Oduncuoglu B, Alaaddinoglu EE. Treatment of Peri-implant Bone Defects with Platelet-Rich Fibrin. Int J Periodontics Restorative Dent. 2015 May-Jun;35(3):415-22. doi: 10.11607/prd.1861.

  PMID: 25909530 RESULT

MeSH Terms

Conditions

Peri-Implantitis; Bone Resorption

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Bone Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Giovanni Salvi, MD

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Stähli, MD

CONTACT

+41316840727; alexandra.staehli@unibe.ch

Jean-Claude Imber, MD

CONTACT

+41316840729; jean-claude.imber@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome measures are being assessed by a clinician blinded to the patient allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Parallel armed, randomised, single-blinded, controlled, clinical trial

Study Record Dates

• First Submitted: November 5, 2024
• First Posted: November 7, 2024
• Study Start: February 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)