The Effects of Adjunctive PRF and i-PRF Applications on GCF Levels of IL-1ß, TNF-α, IL-6, OPG and RANKL in Non-surgical Periodontal Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Change in probing depth (PD)
研究概览
简要总结
The goal of this clinical trial is to learn if adding platelet-rich fibrin (PRF) or injectable platelet-rich fibrin (i-PRF), obtained from the participant's own blood, to standard non-surgical periodontal treatment helps improve gum health in individuals with periodontitis. It will also assess how these applications affect inflammation and bone-related markers in the gum fluid. The main questions it aims to answer are :
- Does the application of PRF or i-PRF improve clinical periodontal healing compared to standard treatment alone?
- Do these applications influence the levels of inflammatory and bone metabolism-related biomarkers in gingival crevicular fluid? Researchers will compare patients receiving PRF or i-PRF in addition to standard periodontal treatment with those receiving standard treatment alone. In addition, the findings obtained from individuals with periodontal disease will be compared with data from periodontally healthy individuals.
Participants will:
- Receive standard periodontal treatment (scaling and root planing)
- Receive PRF or i-PRF depending on their assigned group
- Visit the clinic before treatment and at 2, 4, and 6 weeks after treatment for checkups
详细描述
his study was designed as a randomized controlled clinical trial to evaluate the adjunctive effects of platelet-rich fibrin (PRF) and injectable platelet-rich fibrin (i-PRF) in individuals with periodontitis undergoing non-surgical periodontal therapy (NSPT).
A total of 56 participants were included in the study, comprising 42 systemically healthy patients diagnosed with periodontitis and 14 systemically and periodontally healthy individuals serving as controls. Periodontitis patients were randomly allocated into three treatment groups using a sealed-envelope method: NSPT alone (scaling and root planing, SRP), NSPT with adjunctive PRF application, and NSPT with adjunctive i-PRF application.
PRF and i-PRF were prepared from autologous venous blood obtained from the participants and were applied locally into periodontal pockets immediately following SRP.
Clinical periodontal parameters were recorded at baseline and at the 2nd, 4th, and 6th weeks following treatment. Gingival crevicular fluid (GCF) samples were collected at baseline and at the 2nd and 6th weeks. The levels of inflammatory cytokines (IL-1β, TNF-α, IL-6) and bone metabolism-related biomarkers (OPG and RANKL) in GCF were quantified using enzyme-linked immunosorbent assay (ELISA).
The findings of this study provided insight into the potential clinical and biochemical benefits of PRF and i-PRF as adjunctive approaches in NSPT and allowed comparison with periodontally healthy conditions.
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
- Single (Participant)
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
- •Voluntary consent to participate in the study
- •Individuals aged 18 years or older
- •Systemically healthy individuals
- •Abstaining from the use of any drugs for any purpose
- •No periodontal treatment history in the past six months
- •Individuals who do not smoke
排除标准
- •Absence of willingness to engage in the studies
- •Individuals under the age of 18
- •Existence of any systemic disease influencing periodontal condition and consistent medication usage
- •Administration of local or systemic antibiotics within the preceding six months
- •Chronicle of periodontal therapy during the past six months
- •History of any periodontal surgical intervention within the past 12 months
- •Pregnancy or lactation in female subjects
- •Teeth with endodontic lesion or mobility degrees 2 and 3
研究组 & 干预措施
Non-surgical periodontal therapy (NSPT)
Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). No adjunctive biomaterial was applied.
干预措施: Non-surgical periodontal therapy (NSPT) (Procedure)
NSPT + i-PRF
Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, injectable platelet-rich fibrin (i-PRF) was applied into periodontal pockets.
干预措施: Injectable platelet-rich fibrin (i-PRF) (Biological)
NSPT + PRF
Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, platelet-rich fibrin (PRF) was applied into periodontal pockets.
干预措施: Non-surgical periodontal therapy (NSPT) (Procedure)
NSPT + i-PRF
Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, injectable platelet-rich fibrin (i-PRF) was applied into periodontal pockets.
干预措施: Non-surgical periodontal therapy (NSPT) (Procedure)
Healthy control
Periodontally and systemically healthy participants were included as controls. No periodontal treatment was performed. Gingival crevicular fluid (GCF) samples were collected, and oral hygiene instructions were provided
NSPT + PRF
Participants received non-surgical periodontal therapy (NSPT), including full-mouth scaling and root planing (SRP). Following NSPT, platelet-rich fibrin (PRF) was applied into periodontal pockets.
干预措施: Platelet-rich fibrin (PRF) (Biological)
结局指标
主要结局
Change in probing depth (PD)
时间窗: Baseline, 2 weeks, 4 weeks, and 6 weeks
Change in probing depth (PD) measured in millimeters at six sites per tooth using a periodontal probe, comparing baseline values with follow-up measurements.
次要结局
- Change in clinical attachment level (CAL)(Baseline, 2 weeks, 4 weeks, and 6 weeks)
- Change in plaque index (PI)(Baseline, 2 weeks, 4 weeks, and 6 weeks)
- Change in gingival index (GI)(Baseline, 2 weeks, 4 weeks, and 6 weeks)
- Change in bleeding on probing (BoP)(Baseline, 2 weeks, 4 weeks, and 6 weeks)
- Change in gingival crevicular fluid (GCF) IL-1β levels(Baseline, 2 weeks, and 6 weeks)
- Change in gingival crevicular fluid (GCF) TNF-α levels(Baseline, 2 weeks, and 6 weeks)
- Change in gingival crevicular fluid (GCF) IL-6 levels(Baseline, 2 weeks, and 6 weeks)
- Change in gingival crevicular fluid (GCF) OPG levels(Baseline, 2 weeks, and 6 weeks)
- Change in gingival crevicular fluid (GCF) RANKL levels(Baseline, 2 weeks, and 6 weeks)
研究者
IREM OZCEYLAN
principle investigator, periodontist
Ondokuz Mayıs University