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

Not Applicable

Recruiting

• Conditions: Peri-Implantitis; Bone Resorption; Platelet-Rich Fibrin

• Registration Number: NCT06679283
• Lead Sponsor: University of Bern

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.

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 Timeline

• Study First Submitted: 2024-11-05
• Study First Submitted QC: 2024-11-05
• Study First Posted: 2024-11-07
• Status Verified: 2025-02
• Study Start: 2025-02-01
• Last Update Submitted: 2025-02-04
• Last Update Posted: 2025-02-07
• Primary Completion: 2026-12-01
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Radiographic defect fill after 12 months	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.

Secondary Outcome Measures

Name	Time	Method
Change of probing pocket depth	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.
Change in bleeding on probing	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.
Soft tissue healing	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.
Radiographic and clinical composite index	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.
Patient-reported outcome pain assessed by visual analogue scale (VAS)	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.
Keratinized/attached tissue width	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

Trial Locations

Locations (1)

Department of Periodontology, University of Bern; 🇨🇭 Bern, Switzerland