PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy

University of Bern20 enrolled

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.

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.

Study Type

INTERVENTIONAL

Interventions

PRF as adjunct to non-surgical mechanical debridementBIOLOGICAL

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 aloneBIOLOGICAL

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.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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

Time frame: 6 months follow-up

Secondary Outcomes

Change in PPD after 3 months

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

Time frame: 3 months follow-up

Change in clinical attachment level (CAL)

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

Time frame: 3 months and 6 months follow-up

Frequency of residual pockets

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

Time frame: 3 months and 6 months follow-up

Full-mouth bleeding score (FMBS)

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)

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

Gingival Recession (REC)

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

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

Comparison in PPD change between smokers and non-smokers

Differences in outcome measures will be assessed

Time frame: 3 months and 6 months follow-up

Levels of periodontal bacteria

Levels of periodontal bacteria will assessed by multiplex Polymerase Chain Reaction

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

Comparison of periodontal bacteria between smokers and non-smokers

Levels of periodontal bacteria will assessed by multiplex PCR

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

Levels of Interleukin (IL)-1beta