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NCT Number: NCT07013682

PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy

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.

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Key information

Conditions

Periodontitis Mouth Diseases Periodontal Atrophy Periodontal Attachment Loss Periodontal Diseases Periodontal Inflammation Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

The primary objective of this study is to determine whether scaling and root planing (SRP) combined with the application of a platelet-rich fibrin (PRF) membrane can improve clinical outcomes. Specific outcomes to be measured include reduction in probing pocket depth (PPD), gain in clinical attachment level (CAL), improvement in plaque index, gingival index, and minimization of gingival recession (GR) compared to SRP therapy alone after 3 and 6 months. Further patients reported pain outcomes as well as bacterial profiles and inflammatory markers will be checked.

Patients presenting with periodontitis stage II-IV will be included having at least 20 teeth.

The study includes multiple timepoints: a screening visit, a visit for full-mouth non-surgical treatment with and without PRF in a split-mouth design, a 7-day follow-up visit, a 3-month follow-up visit, and a final assessment 6 months after the non-surgical therapy.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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

Treatment and study plan

PRF as adjunct to non-surgical mechanical debridement

Biological

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.

Control, non-surgical mechanical debridement alone

Biological

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.

Primary outcomes

  1. Change in PPD after 6 months

    Time frame: 6 months follow-up

    Changes in probing depths measured with a periodontal probe in mm from baseline to 6 months after non-surgical periodontal therapy

Secondary outcomes

  1. Change in PPD after 3 months

    Time frame: 3 months follow-up

    Changes in probing depths measured with a periodontal probe in mm from baseline to 3 months after non-surgical periodontal therapy

  2. Change in clinical attachment level (CAL)

    Time frame: 3 months and 6 months follow-up

    The distance in millimeters from the cement-enamel junction (CEJ) to the bottom of the periodontal pocket. This will be assessed using a periodontal probe with mm scale

  3. Frequency of residual pockets

    Time frame: 3 months and 6 months follow-up

    The number of probing depth of > 5 mm will be assessed

  4. Full-mouth bleeding score (FMBS)

    Time frame: Baseline, 3 months and 6 months follow-up

    Percentage of tooth sites (six sites) revealing the presence of bleeding on probing to the bottom of the periodontal pocket. For this a periodontal probe with mm scale will be used, a score of 0% will represent perfect hygiene and 100% plaque on all surfaces (worst value)

  5. Gingival Recession (REC)

    Time frame: Baseline, 3 months and 6 months follow-up

    The distance in millimeters from the gingival margin to the cemento-enamel junction (CEJ). The measurements will be performed with a periodontal probe with a mm scale

  6. Comparison in PPD change between smokers and non-smokers

    Time frame: 3 months and 6 months follow-up

    Differences in outcome measures will be assessed

  7. Levels of periodontal bacteria

    Time frame: Baseline, 3 months and 6 months follow-up

    Levels of periodontal bacteria will assessed by multiplex Polymerase Chain Reaction

  8. Comparison of periodontal bacteria between smokers and non-smokers

    Time frame: Baseline, 3 months and 6 months follow-up

    Levels of periodontal bacteria will assessed by multiplex PCR

  9. Levels of Interleukin (IL)-1beta

    Time frame: Baseline, 7 days, 3 months and 6 months follow-up

    Levels in gingival crevicular fluid will be assessed with ELISA assays

  10. Levels of Matrix metalloproteinase (MMP)-8

    Time frame: Baseline, 7 days, 3 months and 6 months follow-up

    Levels in gingival crevicular fluid will be assessed with ELISA assays

  11. Levels of IL-8

    Time frame: Baseline, 7 days, 3 months and 6 months follow-up

    Levels in gingival crevicular fluid will be assessed with ELISA assays

  12. Comparison between smokers and non-smokers in levels of IL-1beta

    Time frame: Baseline, 7 days, 3 months and 6 months follow-up

    Levels in gingival crevicular fluid will be assessed with ELISA assays

  13. Comparison between smokers and non-smokers in levels of MMP-8

    Time frame: Baseline, 7 days, 3 months and 6 months follow-up

    Levels in gingival crevicular fluid will be assessed with ELISA assays

  14. Comparison between smokers and non-smokers in levels of IL-8

    Time frame: Baseline, 7 days, 3 months and 6 months follow-up

    Levels in gingival crevicular fluid will be assessed with ELISA assays

  15. Antimicrobial activity of PRF

    Time frame: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline

    Remnants of PRF will be used for assessment of antimicrobial activity

  16. Comparison between smokers and non-smokers in antimicrobial activity of PRF

    Time frame: At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline

    Remnants of PRF will be used for assessment of antimicrobial activity

  17. Patient reported pain outcomes

    Time frame: Each day from day 1 to 7 after non-surgical periodontal therapy

    A visual analogue scale (100 mm) will be used for the left and right side of the jaw to quantify pain levels. 0 will be no pain at all and 100 mm the worst imaginable level of pain.

Study contacts

Contact information is provided by the study sponsor or research team.

Alexandra Stähli, DMD

CONTACT

[email protected]

+41 79 387 15 14

Jean-Claude Imber, DMD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

University of Bern

Other

Registry information

Official study title

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

Acronym: PRFSTEP2

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jun 10, 2025
Registry last updated
Jul 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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