Evaluation of the Effects of Injectable Platelet-rich Fibrin (i-PRF) Application on Periodontal Clinical and Biochemical Parameters in Gingival Crevicular Fluid (GCF) in Non-surgical Periodontal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- GCF VEGF levels in test and control groups
研究概览
简要总结
Injectable platelet-rich fibrin, a platelet concentrate in a liquid formulation, has been developed to provide clinicians with ease of use alone or in combination with various biomaterials. The low-speed centrifugation method provides a significant advantage to the regeneration process with richer platelets, leukocytes, and growth factors. It also contributes to the wound-healing process by increasing vascularization. It is expected that the application of injectable platelet-rich fibrin into the gingival pocket following subgingival curettage in periodontitis patients will positively affect the results of non-surgical periodontal treatment. For this reason, in this study it was aimed to investigate the early effects of injectable PRF applied into the pocket for root surface biomodification following subgingival curettage in periodontal pockets of 6 mm and above, by evaluating both clinical parameters and inflammatory and healing markers in the gingival groove fluid
详细描述
The study was planned as a randomized controlled split-mouth clinical trial. A split-mouth design was used to better assess how the same host responded to two different treatment modalities. Two quadrants with contralateral deep periodontal pockets in each participant were selected and randomly divided into test and control groups.
Test group: Injectable platelet-rich fibrin application into the selected deep periodontal pocket after scaling and root planning (SRP) procedure.
Control group: No agent was applied to the periodontal pocket after scaling and root planning.
On the first visit, clinical periodontal measurements were taken before the SRP procedure. Plague index (PI), gingival index (GI), probing depth (PD), clinical attachment level (CAL), and bleeding on probing (BOP) were used as clinical periodontal parameters.
After 1 week, the patients were called again for the SRP procedure. Injectable PRF obtained from the intravenous blood sample taken from the antecubital vein of the patients was injected into the deepened periodontal pocket subgingivally after the SRP procedure in the test group. Clinical periodontal measurements at 1 month and 3 months after SRP were repeated.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •patients with stage 3 grade B periodontitis
排除标准
- •patients with systemic disease
- •pregnant and breastfeeding
- •acute or chronic infection in the past 6 months
- •Use of systemic antibiotic therapy in the past 6 months
- •use of drugs that can affect periodontal health
- •receiving hormone therapy
- •teeth with endodontic lesions
- •Teeth with class 2 and 3 mobility
结局指标
主要结局
GCF VEGF levels in test and control groups
时间窗: Change from Baseline GCF VEGF levels at 3rd and 7th days
measure and compare the improvement of VEGF in test and control groups by using ELISA
Plaque index (PI)
时间窗: Change from Baseline PI at 3rd and 7th days
measure and compare the improvement of PI in test and control groups using a scale
GCF IL-10 levels in test and control groups
时间窗: Change from Baseline GCF IL-10 levels at 3rd and 7th days
measure and compare the improvement of IL-10 in test and control groups by using ELISA
Clinical attachment level (CAL)
时间窗: Change from Baseline CAL at 3rd and 7th days
measure the distance from the cemento-enamel line to the bottom of the pocket and compare the improvement in test and control groups
GCF TNF-alpha levels in test and control groups
时间窗: Change from Baseline GCF TNF-alpha levels at 3rd and 7th days
measure and compare the improvement of TNF-alpha in test and control groups by using ELISA
Probing depth (PD)
时间窗: Change from Baseline PD levels at 3rd and 7th days
measure the gingival margin to pocket bottom as mm and compare the improvement of PD in test and control groups
Gingival index (GI)
时间窗: Change from Baseline GI at 3rd and 7th days
measure and compare the improvement of GI in test and control groups using a scale
Bleeding on probing (BOP)
时间窗: Change from Baseline BOP at 3rd and 7th days
Whether there is bleeding when the periodontal pocket is probed and comparing the improvement in test and control groups
次要结局
未报告次要终点
研究者
AYSAN LEKTEMUR ALPAN
Associate Profesor
Pamukkale University