Evaluation of the Clinical and Biochemical Efficacy of Repeated Injectable Platelet-Rich Fibrin Application Following Scaling and Root Planing in Patients With Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Changes in GCF levels of TGF-β and PDGF at multiple time points.
研究概览
简要总结
The goal of this clinical trial is to learn if a treatment called injectable platelet-rich fibrin (i-PRF) helps improve gum health in people with a type of gum disease called Stage 3 Grade B periodontitis.
The main questions this study aims to answer are:
Does i-PRF help reduce gum inflammation and support healing? Are there changes in certain biological markers after using i-PRF? Researchers will compare two sides of the mouth. One side will receive i-PRF, and the other will be treated with salt water (saline) as a comparison.
Participants will:
Have a dental cleaning called scaling and root planing (SRP) Get i-PRF injected into deep gum pockets on one side of the mouth Have salt water placed in the other side's gum pockets Give gum fluid samples and have gum measurements taken at several visits (including 3 months later) Provide a small blood sample to prepare the i-PRF Researchers will collect and study gum fluid and look at markers related to healing and inflammation. The study will help find out if i-PRF is useful as a new treatment option for gum disease.
详细描述
A total of 20 patients diagnosed with Stage 3 Grade B Periodontitis based on clinical and radiographic findings will be included in this study at the Department of Periodontology, Faculty of Dentistry, Gülhane University. Eligible participants will be systemically healthy, non-smokers, not pregnant or breastfeeding, not on any medications, and must not have received any periodontal treatment or antibiotics within the past six months.
All participants will be informed about the study in detail, and written and verbal informed consent will be obtained from those who voluntarily agree to participate.
The study will be designed as a randomized controlled split-mouth clinical trial, in which the periodontal pockets in one half of the mouth will serve as the test site, and those in the other half will serve as the control site. Allocation of test and control sides will be determined by coin toss. Baseline and 3-month clinical periodontal parameters - including Plaque Index (PI), Gingival Index (GI), Bleeding on Probing (BOP), Probing Pocket Depth (PPD) and Clinical Attachment Level (CAL) will be recorded using a Williams periodontal probe.
For biochemical analysis, gingival crevicular fluid (GCF) samples will be collected from the deepest periodontal pockets at the test and control sites at four time points: baseline, 7 days after the first application of injectable platelet-rich fibrin (i-PRF), 7 days after the second application, and at 3 months. GCF collection will be performed using Periopaper strips after isolating the area with cotton rolls and gently removing supragingival plaque. Strips will be inserted into the pocket until resistance is felt, held in place for 15 seconds, and then analyzed for volume using a Periotron device. Samples will then be stored in Eppendorf tubes at -80°C until biochemical analysis. Levels of Platelet Factor-4 (PF-4), Myeloperoxidase (MPO), Transforming Growth Factor Beta (TGF-β), and Platelet-Derived Growth Factor (PDGF) in GCF will be analyzed using ELISA.
Following baseline measurements and GCF sampling, scaling and root planing (SRP) will be performed in two sessions, spaced one week apart, using standard ultrasonic and hand instruments (curettes and Gracey curettes).Venous blood samples (15 ml) will be drawn from the antecubital vein using sterile syringes and transferred into two plain tubes. The samples will be centrifuged at 1000 rpm for 3 minutes. The injectable platelet-rich fibrin (i-PRF) from the upper layer will be collected using a 5 ml syringe and administered into all deep periodontal pockets (≥4 mm) in the test quadrant. The application will be followed by gentle digital compression with a gauze sponge for 1 minute to allow polymerization and retention of the material.
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
- Single (Participant)
盲法说明
In addition to masking the participants, the researcher who performed the biochemical analyses was also masked.
入排标准
- 年龄范围
- 18 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Being diagnosed with Stage 3 Grade B periodontitis
- •Being between the ages of 18-65
排除标准
- •Having a systemic disease
- •Taking any medication
- •Being pregnant or breastfeeding
- •Having received chemotherapy, radiotherapy or immunosuppressant treatments
- •Having received periodontal treatment in the last 6 months
- •Having used antibiotics in the last 6 months
研究组 & 干预措施
Test Site
Repeated application of İ-PRF to periodontal pockets in the test sites.
干预措施: İnjectable platelet-rich fibrin (Biological)
Control Site
Control sites received a sham intervention consisting of sterile saline solution irrigation into the periodontal pockets, to mimic the procedural aspects of PRF placement without delivering any biologically active material.
干预措施: Sterile saline (0.9%) (Other)
结局指标
主要结局
Changes in GCF levels of TGF-β and PDGF at multiple time points.
时间窗: From baseline to third month
Biochemical markers will be analyzed at baseline, 2 weeks, 4 weeks, and 3 months. The biochemical data will be correlated with clinical periodontal parameters to assess the relationship between molecular changes and clinical outcomes, thereby providing a comprehensive evaluation of treatment efficacy.
Changes in clinical periodontal parameters, including Probing Pocket Depth and Clinical Attachment Level, will be evaluated at baseline and at the third month.
时间窗: From baseline to third month
Clinical data will be evaluated at baseline and at the third month.
次要结局
- Changes in GCF levels of PF 4 and MPO at multiple time points.(From baseline to third month)
- Changes in clinical periodontal parameters, including Plaque Index, Gingival Index, and Bleeding on Probing evaluated at baseline and at the third month.(From baseline to third month)
