PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy

Official title

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

Overview

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.

Detailed description

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.

Interventions

• Biological PRF 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.
• Biological Control, 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.

Primary outcome measures

• Change in PPD after 6 months [Time frame: 6 months follow-up]

Secondary outcome measures (12)

• Change in PPD after 3 months [Time frame: 3 months follow-up]
• Change in clinical attachment level (CAL) [Time frame: 3 months and 6 months follow-up]
• Frequency of residual pockets [Time frame: 3 months and 6 months follow-up]
• Full-mouth bleeding score (FMBS) [Time frame: Baseline, 3 months and 6 months follow-up]
• Gingival Recession (REC) [Time frame: Baseline, 3 months and 6 months follow-up]
• Comparison in PPD change between smokers and non-smokers [Time frame: 3 months and 6 months follow-up]
• Levels of periodontal bacteria [Time frame: Baseline, 3 months and 6 months follow-up]
• Comparison of periodontal bacteria between smokers and non-smokers [Time frame: Baseline, 3 months and 6 months follow-up]
• Levels of Interleukin (IL)-1beta [Time frame: Baseline, 7 days, 3 months and 6 months follow-up]
• Levels of Matrix metalloproteinase (MMP)-8 [Time frame: Baseline, 7 days, 3 months and 6 months follow-up]
• Levels of IL-8 [Time frame: Baseline, 7 days, 3 months and 6 months follow-up]
• Comparison between smokers and non-smokers in levels of IL-1beta [Time frame: Baseline, 7 days, 3 months and 6 months follow-up]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Crossover

Masking

Double blind

Primary purpose

Treatment

Study locations

Switzerland · 1 center

• Department of Periodontology, University of Bern — Bern

Identifiers

NCT: NCT07013682 · PRF2

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗