Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
Healthy Volunteers
ID06679283

Surgical Treatment of Peri-implantitis With Adjunctive Platelet Rich Fibrin Compared With Open Flap Debridement Alone: A 12-month Randomised Clinical Trial

Led by University of Bern · Updated on 2026-03-30

40

Participants Needed

1

Research Sites

56 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating the use of platelet-rich fibrin (PRF), a natural blood-derived product rich in growth factors, to enhance healing and bone regeneration in peri-implantitis, a chronic infection causing inflammation and bone loss around dental implants. This study aims to compare surgical cleaning of peri-implantitis defects combined with PRF application to surgical cleaning alone, assessing improvements in tissue regeneration and healing. The trial is randomized and evaluates outcomes over 12 months using clinical and radiographic measures. The study involves two groups: one receiving open flap debridement with a chemo-electric device plus PRF clots and membranes applied into the defect, and the other receiving the same debridement and detoxification without PRF. Blood is drawn for PRF preparation in the treatment group, and after surgical cleaning, the flap is closed in both groups. Implants with similar defect sizes are randomly assigned to either group for comparison. Participants will undergo clinical evaluations including radiographic defect fill, probing pocket depth, bleeding on probing, and soft tissue healing indices at baseline and after 12 months. Patient-reported pain is also measured using a visual analog scale shortly after surgery. The study includes monitoring of keratinized tissue width and composite clinical indices to assess treatment effects. The total participation period includes follow-ups at multiple time points within one year post-surgery.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • One or more peri-implant sites with pocket probing depth of 5 mm or more combined with bleeding or suppuration
  • Peri-implant marginal bone loss with crater-like defect of 3 mm or more seen on intraoral radiographs
  • Good oral hygiene with plaque index less than 20%
  • Written informed consent
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • History of chronic inflammatory disease
  • Severe systemic diseases
  • Medically confirmed diagnosis of diabetes mellitus
  • Use of anti-inflammatory medications including prednisone
  • Smoking more than 5 cigarettes per day
  • Pregnant or lactating women
  • Under 18 years of age

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Up to 14 days

Participants undergo surgical treatment involving open flap debridement with implant surface cleaning. Depending on group assignment, PRF clots and membranes may be applied to the defect before closing the flap. Soft tissue healing is monitored shortly after surgery.

3 visits (2 days, 7 days, and 14 days post-surgery)

Post-operative Follow-up

Duration - 12 months

Participants return for follow-up visits to assess radiographic defect fill, clinical parameters including probing pocket depth and bleeding on probing, keratinized tissue width, and patient-reported outcomes over a period of 12 months after surgery.

2 visits (baseline and 12-month follow-up)

Trial Site Locations

Total: 1 location

1

Department of Periodontology, University of Bern

Bern, Switzerland, 3010

Actively Recruiting

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Research Team

A

Alexandra Stähli, MD

J

Jean-Claude Imber, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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Published Research Related To This Trial

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.

Tord Berglundh, Gary Armitage, Mauricio G Araujo...

https://pubmed.ncbi.nlm.nih.gov/29926491

Evidence of re-osseointegration after electrolytic cleaning and regenerative therapy of peri-implantitis in humans: a case report with four implants.

Dieter D Bosshardt, Urs R Brodbeck, Florian Rathe...

https://pubmed.ncbi.nlm.nih.gov/35244779

Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part III: leucocyte activation: a new feature for platelet concentrates?

David M Dohan, Joseph Choukroun, Antoine Diss...

https://pubmed.ncbi.nlm.nih.gov/16504851

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.

A R Pradeep, Shruti Karvekar, Kanika Nagpal...

https://pubmed.ncbi.nlm.nih.gov/26439386