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

March 24, 2026 updated by: University of Bern

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Peri-implantitis is a chronic inflammatory condition around dental implants, associated with biofilm-mediated infection. The initial stage involves the formation of a bacterial biofilm in the peri-implant tissue, resulting in mucositis, which is characterized by erythema, bleeding, exudation, and swelling. With continued biofilm accumulation, mucositis can progress to peri-implantitis, which is marked by bone destruction. Due to varying definitions of peri-implantitis, the VIII European Workshop on Periodontology established diagnostic criteria, specifying progressive bone loss of ≥ 2 mm with clinical signs of inflammation. Recently, the American Academy of Periodontology and the European Federation of Periodontology suggested a threshold of ≥ 3 mm. Based on these definitions, recent meta-analyses have shown the prevalence of peri-implantitis to be approximately 18.5% at the patient level and 12.8% at the implant level, highlighting an increasingly significant problem within the global adult population.

Currently, treating peri-implantitis is challenging, costly, and often unpredictable. The primary goals of therapy are to resolve soft-tissue inflammation and stabilize the bony attachment. This requires effective removal of bacterial biofilms and deposits from implant surfaces to enable healing on a biologically clean surface. Peri-implantitis therapy often necessitates a surgical approach that includes surface decontamination with or without the use of a bone substitute. Despite these interventions, surgically treated cases demonstrate a high failure rate, with approximately 60% of cases showing recurrence, underscoring the need for innovative therapeutic approaches.

PRF has recently emerged as a viable alternative to recombinant growth factors due to its ability to support healing naturally. It is obtained by centrifuging blood to create a coagulated plasma that includes a complex mixture of growth factors within a fibrin network. This plasma can be further processed to extract a PRF membrane by squeezing out the serum. PRF membranes are increasingly used to enhance clinical outcomes by delivering growth factors at surgical sites, either alone or in combination with dental implants and collagen membranes.

This project aims to determine whether PRF enhances regeneration in peri-implantitis defects and to compare the outcomes of surgical debridement and implant detoxification combined with PRF clot and membrane placement, against debridement and detoxification alone. For this purpose, implants with peri-implantitis defects of comparable size will be randomly assigned to either the test or control group.

Study Endpoints:

Radiographic defect fill after one year, with a cut-off level of > 1.0 mm Clinical parameters: probing pocket depth (PPD), bleeding on probing (BoP), and keratinized tissue amount in mm on the oral and buccal implant sides Soft tissue healing as assessed by the Early Wound Healing Index by Wachtel Composite clinical index based on criteria established by Renvert et al. (2018) Patient-reported outcomes assessed through a visual analog scale

Study Type

Interventional

Enrollment (Estimated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

Exclusion Criteria:

  1. History of chronic inflammatory disease
  2. Severe systemic diseases
  3. Medically confirmed diagnosis of diabetes mellitus
  4. Anti-inflammatory prescription including prednisone
  5. Smoking > 5 cigarettes
  6. Pregnant or lactating women
  7. < 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Open flap debridement with a chemo-electric device + PRF
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
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.
Active Comparator: Open flap debridement with a chemo-electric device alone
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)
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic defect fill after 12 months
Time Frame: Baseline, 12-month follow-up
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of probing pocket depth
Time Frame: Baseline, 12-month follow-up
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.
Baseline, 12-month follow-up
Change in bleeding on probing
Time Frame: Baseline, 12-month follow-up
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.
Baseline, 12-month follow-up
Soft tissue healing
Time Frame: 2 days post-surgery, 7 days and 14 days post-surgery
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.
2 days post-surgery, 7 days and 14 days post-surgery
Radiographic and clinical composite index
Time Frame: Baseline, 12-month follow-up
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.
Baseline, 12-month follow-up
Patient-reported outcome pain assessed by visual analogue scale (VAS)
Time Frame: 2 days post-surgery, 7 days and 14 days post-surgery
A 100 mm scale for pain will be used. Patient will be asked to mark their pain sensation with 0 representing no pain at all and 100 mm representing the worst imaginable pain. The time to recovery defined as pain <10 mm will be assessed.
2 days post-surgery, 7 days and 14 days post-surgery
Keratinized/attached tissue width
Time Frame: Baseline, 12-month follow-up
The attached mucosa around an implant might be decisive for peri-implant health by facilitating oral hygiene. Keratinized tissue is mostly attached to the underlying bone. Keratinized tissue width will be measured as the distance from the mucosal margin to the border of the movable and lining mucosa. Lugol's solution will be used to discern the tissue border. The distance will be measured with a periodontal probe with mm markings. The keratinized/attached mucosa width will be measured at baseline and after 12 months
Baseline, 12-month follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bern

Investigators

  • Principal Investigator: Giovanni Salvi, MD, University of Bern

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

November 5, 2024

First Submitted That Met QC Criteria

November 5, 2024

First Posted (Actual)

November 7, 2024

Study Record Updates

Last Update Posted (Actual)

March 30, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bone Resorption

Clinical Trials on Open flap debridement with a chemo-electric device + PRF

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Colombia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe