RecruitingNot ApplicableNCT07013682

PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy

Platelet Rich Fibrin Adjunctive to Non-surgical Periodontal Therapy: a 6-month Split-mouth Randomized Controlled Clinical Trial


Sponsor

University of Bern

Enrollment

20 participants

Start Date

May 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

Periodontitis is characterized by a chronic, multifactorial inflammatory process driven by dysbiotic plaque biofilms. It is recognized as the most common chronic inflammatory non-communicable disease in humans. The advanced and severe forms of periodontitis have an estimated prevalence of 7.4%, while milder forms can affect up to 50% of the population. If left untreated, periodontitis can lead to tooth loss. However, it is largely preventable and treatable with mechanical non-surgical periodontal therapy. To improve periodontal healing and thus clinical attachment gain after non-surgical therapy, adjunctive bioactive formulations such as enamel matrix derivatives, sodium hypochlorite, locally delivered antimicrobials, or hyaluronic acid have recently been proposed. However, these agents are non-autologous formulations and expensive. Platelet-rich fibrin (PRF) acts as a scaffold that inhibits the early migration of epithelial cells into the periodontal tissues. Its regenerative properties are primarily due to its ability to promote angiogenesis. This ability is attributed to the 3D fibrin matrix, which can simultaneously transport several cytokines and growth factors. These include vascular endothelial growth factor (VEGF), insulin growth factor (IGF), transforming growth factor β1 (TGF-β1) and platelet-derived growth factor (PDGF). PRF further shows antibacterial properties and accelerates soft tissue healing. So far PRF is not routinely used in periodontal non-surgical therapy. The aim of this 6-month, split-mouth randomized clinical trial including 20 patients is to test whether PRF can improve the results after non-surgical therapy.


Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Men and women aged ≥ 18 years
  • Periodontitis stage II-IV, grade A/B/C, generalized
  • Presence of at least 20 teeth (excluding wisdom teeth)
  • Absence of removable dentures
  • Patients willing to provide written informed consent and to complete the 6- month study follow-up

Exclusion Criteria10

  • Patients already participating in other clinical trials
  • Periodontal treatment in the previous 12 months
  • Antibiotic treatment 3 months prior to study entry
  • Antibiotic prophylaxis required for dental treatment
  • Current use of any medication that may affect the clinical features of periodontitis
  • Pregnant/lactating
  • Any condition that prevents venipuncture
  • Not willing to venous puncture
  • Current cancer treatment
  • History of radiation in the head-neck area

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Interventions

BIOLOGICALPRF as adjunct to non-surgical mechanical debridement

Non-surgical mechanical debridement with hand and power-driven instruments will be performed. Venous blood will be harvested from the patient and centrifuged. Immediately afterwards, the PRF will be inserted in all pockets of the allocated side of the jaw in all pockets ≥ 5 mm.

BIOLOGICALControl, non-surgical mechanical debridement alone

Non-surgical mechanical debridement with hand and power-driven instruments will be performed. Venous blood will be harvested from the patient and centrifuged. Immediately afterwards, an empty sy will be inserted in all pockets of the allocated control side of the jaw in all pockets ≥ 5 mm.


Locations(1)

Department of Periodontology, University of Bern

Bern, Switzerland

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NCT07013682


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