The Effect of Titanium- Platelet Rich Fibrin in Periodontal Intrabony Defects: A Randomized Controlled Split-Mouth Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- site-specific plaque index (PI) (Silness & Loe)
研究概览
简要总结
In this study, the possible effect of blood group distribution on the content of blood biomaterial was investigated. 64 volunteers were included in the study. Various parameters were evaluated. As a result, it was concluded that blood group distribution does not affect blood biomaterial content.
详细描述
The aim of this split-mouth, randomized, and controlled study was to compare open flap debridement (OFD) alone against OFD with autogenous Titanium-prepared platelet-rich fibrin (OFD+ T-PRF) combined in treating intrabony defects (IBD). Subjects were 20 systemically healthy patients with chronic periodontitis according to 2017 World Workshop. Bilateral operation sites in patients (40 sites) were randomly selected for OFD alone or OFD+ T-PRF combined. Clinical parameters (probing depth (PD), relative attachment level (RAL), and gingival marginal level(GML)), radiographic parameters (intrabone defects (IBDs) and periodontal bone support (PBS)), and growth factors levels (GFL) in gingival crevicular fluid (GCF) (platelet-derived growth factors (PDGF-BB), fibroblast growth factors (FGF-2), relative ratio of receptor activator nuclear factor kappa-B (RANKL)/osteoprotegerin (OPG)) were analyzed. The Wilcoxon signed-rank test, the Student's t-test, the two way ANOVA, and the Tukey post hoc test were used for statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with bilaterally similar periodontal intrabone defects (IBDs)
排除标准
- •Who did not show the necessary oral hygiene during the non-surgical periodontal treatment process,
- •history of periodontal therapy in the preceding 1 year,
- •presence of devital tooth, Grade II, or higher mobility of the tooth, and less than 3 bone walls or a defect in the furcation at the site of the bone defect,
- •history of any systemic diseases that can alter the course of the periodontal disease,
- •use of antibiotics,
- •pregnant/lactating women.
结局指标
主要结局
site-specific plaque index (PI) (Silness & Loe)
时间窗: 9 month
measurement of plaque accumulated on the tooth surface
modified sulcus bleeding index (mSBI)
时间窗: 9 month
assessment of bleeding gums
probing depth from the gingival margin (PD)
时间窗: 9 month
evaluated from the gingival margin to the base of the pocket
gingival marginal level (GML)
时间窗: 9 month
measured from the apical most end of the stent to the crest of the gingival margin
relative attachment level (RAL)
时间窗: 9 month
evaluated from the cementoenamel junction to the base of the pocket and gingival marginal level
次要结局
- fibroblast growth factors (FGF-2)(12 weeks)
- platelet-derived growth factors (PDGF-BB)(12 weeks)
- Gingival Crevicular Fluid Collection; The gingival crevicular fluid (GCF) sample was collected to biochemically evaluate the patient's periodontal tissue healing.(12 weeks)
研究者
Gurbet Alev OZTAS SAHINER
Principal Investigator
Ataturk University