PRF as Adjunct to Subgingival Instrumentation in Step 2 Periodontal Therapy

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Биопрепарат 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.
• Биопрепарат 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.

Первичные конечные точки

• Change in PPD after 6 months [Срок оценки: 6 months follow-up]

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Швейцария · 1 центр

• Department of Periodontology, University of Bern — Bern

Идентификаторы

NCT: NCT07013682 · PRF2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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