Peri-ImplantitisPRFNCT06679283
Surgical Treatment of Peri-implantitis With Adjunctive Application of Platelet Rich Fibrin (PRF)
A study testing Open flap debridement with a chemo-electric device + PRF in people with Peri-Implantitis and Bone Resorption, run by University of Bern at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Peri-Implantitis, Bone Resorption, Platelet-Rich Fibrin
- What is being tested?
- Open flap debridement with a chemo-electric device + PRF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Department of Periodontology, University of Bern
Bern, 3010
Alexandra Stähli, MD, +41316840729-, alexandra.staehli@zmk.unibe.ch
Jean-Claude Imber, MD, +41 31 632 35 51, jean-claude.imber@unibe.ch
About this study
Official title: 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.
Read the 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
- Conditions
- Peri-Implantitis, Bone Resorption, Platelet-Rich Fibrin
- Being tested
- Open flap debridement with a chemo-electric device + PRF, Open flap debridement with a chemo-electric device alone (control)
- Keywords
- platelet rich fibrin, peri-implantitis
- Medical subject headings
- Peri-Implantitis, Bone Resorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open flap debridement with a chemo-electric device + PRFProcedure or surgery
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 alone (control)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Open flap debridement with a chemo-electric device alone (control) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 12-month follow-up
Secondary outcomes (6)
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.
Measured: Baseline, 12-month follow-up
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.
Measured: Baseline, 12-month follow-up
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.
Measured: 2 days post-surgery, 7 days and 14 days post-surgery
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.
Measured: Baseline, 12-month follow-up
Patient-reported outcome pain assessed by visual analogue scale (VAS)
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.
Measured: 2 days post-surgery, 7 days and 14 days post-surgery
Keratinized/attached tissue width
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
Measured: Baseline, 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start1 Feb 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Peri-ImplantitisStudies of the same condition, open and under way.
- More trials run by University of BernThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel armed, randomised, single-blinded, controlled, clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Bern
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Giovanni Salvi, MD, Principal investigator, University of Bern
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06679283
- Sponsor's protocol ID
- PRF
- Acronym
- PRF
- Status last verified
- Mar 2026
- First submitted
- 5 Nov 2024
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29926491Bosshardt 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.
PubMed 35244779Berglundh 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.
PubMed 1420721Derks 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.
PubMed 25495683Dohan 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.
PubMed 16504851Roccuzzo 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.
PubMed 30328195Lang 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.
PubMed 8329533Miron 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.
PubMed 28551729Pontoriero 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.
PubMed 7640340Pradeep 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.
PubMed 26439386Hamzacebi 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.
PubMed 25909530
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06679283
- Acronym / sponsor ID
- PRF / PRF
- Conditions
- Peri-Implantitis, Bone Resorption, Platelet-Rich Fibrin
- Keywords
- platelet rich fibrin, peri-implantitis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of BernUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 7 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Parallel armed, randomised, single-blinded, controlled, clinical trial
| Arm | Type | Receives |
|---|---|---|
| Open flap debridement with a chemo-electric device + PRF | Experimental | Procedure: Open flap debridement with a chemo-electric device + PRFA 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. |
| Open flap debridement with a chemo-electric device alone | Active comparator | Procedure: Open flap debridement with a chemo-electric device alone (control)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- History of chronic inflammatory disease
- Severe systemic diseases
- Medically confirmed diagnosis of diabetes mellitus
- Anti-inflammatory prescription including prednisone
- Smoking > 5 cigarettes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open flap debridement with a chemo-electric device + PRFThe 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. | Procedure or surgery | Open flap debridement with a chemo-electric device + PRF |
| 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. | Procedure or surgery | Open flap debridement with a chemo-electric device alone |
Primary outcome
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.
6 secondary outcomes
Change of probing pocket depth
Time frame: Baseline, 12-month follow-up
Change in bleeding on probing
Time frame: Baseline, 12-month follow-up
Soft tissue healing
Time frame: 2 days post-surgery, 7 days and 14 days post-surgery
Radiographic and clinical composite index
Time frame: 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
Keratinized/attached tissue width
Time frame: Baseline, 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Background: PubMed 29926491Berglundh 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.
- Background: PubMed 35244779Bosshardt 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.
- Background: PubMed 1420721Berglundh 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.
- Background: PubMed 25495683Derks 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.
- Background: PubMed 16504851Dohan 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.
- Background: PubMed 30328195Roccuzzo 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.
- Background: PubMed 8329533Lang 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.
- Background: PubMed 28551729Miron 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.
- Background: PubMed 7640340Pontoriero 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.
- Background: PubMed 26439386Pradeep 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.
- Results publication: PubMed 25909530Hamzacebi 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.
- Individual participant dataSharing planned: No
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RecruitingObservational study
Access to Probing and Peri-implant Diseases
Peri-implantitis, Peri-implant Bone Loss
Not yet recruitingObservational study
ATR-FTIR and Raman Spectroscopy of Peri-Implant Crevicular Fluid in Peri-Implantitis
Peri-Implantitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Giovanni Salvi, MD principal investigator
University of Bern
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open flap debridement with a chemo-electric device + PRF in people with Peri-Implantitis and Bone Resorption, run by University of Bern at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexandra Stähli, MD (+41316840727, alexandra.staehli@unibe.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic defect fill after 12 months (time frame: Baseline, 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06679283, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.