PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy

NCT07013682 | Recruiting

• 1 other identifier: PRF2
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Periodontitis; Periodontal Inflammation; Periodontal Attachment Loss

Outcome Measures

Primary Outcomes (1)

• Change in PPD after 6 months

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

  6 months follow-up

Secondary Outcomes (17)

• Change in PPD after 3 months

  3 months follow-up

• Change in clinical attachment level (CAL)

  3 months and 6 months follow-up

• Frequency of residual pockets

  3 months and 6 months follow-up

• Full-mouth bleeding score (FMBS)

  Baseline, 3 months and 6 months follow-up

• Gingival Recession (REC)

  Baseline, 3 months and 6 months follow-up

Study Arms (2)

Control side

SHAM COMPARATOR

After non-surgical mechanical debridement of all pockets ≥ 5 mm, an empty syringe will be inserted.

Biological: Control, non-surgical mechanical debridement alone

Test side

ACTIVE COMPARATOR

After non-surgical mechanical debridement of all pockets ≥ 5 mm, PRF will be inserted.

Biological: PRF as adjunct to non-surgical mechanical debridement

Interventions

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.

Test side

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.

Control side

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bern: lead

Study Sites (1)

Department of Periodontology, University of Bern

Bern, 3010, Switzerland

RECRUITING

MeSH Terms

Conditions

Periodontitis; Periodontal Attachment Loss

Interventions

Prolactin-Releasing Hormone

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periodontal Atrophy

Intervention Hierarchy (Ancestors)

Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Nerve Tissue Proteins; Proteins

Study Officials

• Giovanni Salvi, DMD

  University of Bern

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexandra Stähli, DMD

CONTACT

+41 79 387 15 14; alexandra.staehli@unibe.ch

Jean-Claude Imber, DMD

CONTACT

jean-claude.imber@unibe.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Opaque sealed envelopes will held the randomisation key of which side has to be treated with PRF. After completion of the non-surgical mechanical debridement in the whole dentition, the sealed envelope will be opened. PRF will be obtained from the elbow vene and after centrifugation the PRF will be applied in the pockets ≥ 5 mm. On the control side an empty cannula will be held.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a split-mouth study. One side of the mouth (upper and lower jaw) will be treated with adjunctive PRF during non-surgical mechanical therapy and the other without.

Study Record Dates

• First Submitted: June 2, 2025
• First Posted: June 10, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 24, 2026
• Study Completion (Estimated): December 24, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)