Effectiveness of Injectable Platelet Rich Fibrin Used For Root Surface Biomodification On Clinical Periodontal Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Change in probing pocket depth (mm) at treated sites
研究概览
简要总结
This study is designed to evaluate a new method to improve healing in patients with gum disease (periodontitis). A total of 42 adults with gum pockets deeper than 5 millimeters will take part. All patients will undergo flap surgery, which is a standard treatment for gum disease. Half of the patients will also receive an additional treatment with injectable platelet-rich fibrin (i-PRF), made from their own blood, together with root surface cleaning using EDTA gel. Patients will be followed for 6 months. The study will measure changes in gum pocket depth, gum attachment to teeth, and healing.
详细描述
Periodontitis is a chronic inflammatory disease of the tooth-supporting tissues. Open flap debridement (OFD) is a standard surgical approach for the management of deep periodontal pockets. Injectable platelet-rich fibrin (i-PRF) is an autologous, anticoagulant-free platelet concentrate prepared with low-speed centrifugation and characterized by a fibrin network that gradually releases growth factors. Neutral-pH 24% EDTA root-surface conditioning is used to remove the smear layer and expose collagen, which may support early cell attachment and the adsorption of bioactive molecules.
This single-center, randomized, parallel-group, open-label clinical trial is designed to evaluate whether the adjunctive use of i-PRF after EDTA root conditioning provides additional benefits compared with EDTA conditioning alone. Adults with periodontitis will be enrolled at a university periodontal clinic and randomized to one of two groups:
Control group: OFD with 24% EDTA gel conditioning (3 minutes)
Test group: OFD with 24% EDTA gel conditioning (3 minutes) followed by application of i-PRF retained on defect surfaces for 5 minutes
A mixed defect model (sites with both intrabony and horizontal components) will be included to reflect real-world clinical presentations.
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)
盲法说明
Participants were blinded to group allocation; however, investigators and outcome assessors were not blinded due to the surgical nature of the interventions.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18 years and older
- •Diagnosis of Stage II-IV periodontitis
- •Presence of ≥3 adjacent teeth with probing pocket depth (PPD) ≥5 mm
- •Systemically healthy individuals
- •Non-smokers
- •Ability and willingness to comply with oral hygiene instructions and study follow-up visits
排除标准
- •Systemic diseases or conditions affecting periodontal healing (e.g., uncontrolled diabetes, immunodeficiency)
- •Pregnancy or lactation
- •Current or previous smokers
- •Use of medications that may affect periodontal status (e.g., immunosuppressants, bisphosphonates)
- •Previous periodontal treatment within the last 6 months
研究组 & 干预措施
Control - OFD + EDTA
Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning only. No injectable platelet-rich fibrin (i-PRF) was applied.
干预措施: Open Flap Debridement (OFD) (Procedure)
Control - OFD + EDTA
Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning only. No injectable platelet-rich fibrin (i-PRF) was applied.
干预措施: 24% EDTA Root Conditioning (Other)
Test - OFD + EDTA + i-PRF
Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning plus application of injectable platelet-rich fibrin (i-PRF) to the surgical sites before flap closure.
干预措施: Open Flap Debridement (OFD) (Procedure)
Test - OFD + EDTA + i-PRF
Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning plus application of injectable platelet-rich fibrin (i-PRF) to the surgical sites before flap closure.
干预措施: 24% EDTA Root Conditioning (Other)
Test - OFD + EDTA + i-PRF
Participants received open flap debridement (OFD) with 24% EDTA root surface conditioning plus application of injectable platelet-rich fibrin (i-PRF) to the surgical sites before flap closure.
干预措施: Injectable Platelet-Rich Fibrin (i-PRF) (Biological)
结局指标
主要结局
Change in probing pocket depth (mm) at treated sites
时间窗: Baseline and 6 months post-surgery
Measured with a UNC-15 periodontal probe at treated sites.
次要结局
- Change in clinical attachment level (mm) at treated sites(Baseline and 6 months post-surgery)
- Mean Plaque Index (Silness and Löe Index, 0-3 scale)(Baseline, 3 months, and 6 months)
- Change in gingival recession width (mm) at treated sites(Baseline, 3 months, and 6 months)
- Mean Gingival Index (Löe and Silness Index, 0-3 scale)(Baseline, 3 months, and 6 months)
- Percentage of sites with bleeding on probing (%)(Baseline, 3 months, and 6 months)
- Change in gingival recession depth (mm) at treated sites(Baseline, 3 months, and 6 months)
- Visual Analog Scale (VAS, 0-10) scores for pain and sensitivity(Immediately after surgery, Week 1, and Week 2)
- Clinical healing parameters (edema, erythema, necrosis)(Week 1, Week 2, and 1 month post-surgery)
研究者
Halil Ata BIÇAKÇIOGLU
Principal Investigator, PhD, Department of Periodontology, Gazi University Faculty of Dentistry
Gazi University