Platelet Rich Fibrin Adjunctive to Non-surgical Periodontal Therapy: a 6-month Split-mouth Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in PPD after 6 months
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Test side
After non-surgical mechanical debridement of all pockets ≥ 5 mm, PRF will be inserted.
干预措施: PRF as adjunct to non-surgical mechanical debridement (Biological)
Control side
After non-surgical mechanical debridement of all pockets ≥ 5 mm, an empty syringe will be inserted.
干预措施: Control, non-surgical mechanical debridement alone (Biological)
结局指标
主要结局
Change in PPD after 6 months
时间窗: 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
次要结局
- Levels of periodontal bacteria(Baseline, 3 months and 6 months follow-up)
- Comparison of periodontal bacteria between smokers and non-smokers(Baseline, 3 months and 6 months follow-up)
- 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)
- Comparison in PPD change between smokers and non-smokers(3 months and 6 months follow-up)
- Levels of Interleukin (IL)-1beta(Baseline, 7 days, 3 months and 6 months follow-up)
- Levels of Matrix metalloproteinase (MMP)-8(Baseline, 7 days, 3 months and 6 months follow-up)
- Levels of IL-8(Baseline, 7 days, 3 months and 6 months follow-up)
- Comparison between smokers and non-smokers in levels of IL-1beta(Baseline, 7 days, 3 months and 6 months follow-up)
- Comparison between smokers and non-smokers in levels of MMP-8(Baseline, 7 days, 3 months and 6 months follow-up)
- Comparison between smokers and non-smokers in levels of IL-8(Baseline, 7 days, 3 months and 6 months follow-up)
- Antimicrobial activity of PRF(At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline)
- Comparison between smokers and non-smokers in antimicrobial activity of PRF(At visit of Step-2 therapy, expected to be ca. 2-4 weeks after baseline)
- Patient reported pain outcomes(Each day from day 1 to 7 after non-surgical periodontal therapy)