Evaluation of The Periodontal Parameters Following Non-Surgical Periodontal Therapy With and Without Adjunctive Use of Injectable Platelet Rich Fibrin: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical attachment Gain
研究概览
简要总结
This randomized controlled clinical trial aims to evaluate the effectiveness of non-surgical periodontal therapy (NSPT) with and without the adjunctive use of injectable platelet-rich fibrin (I-PRF) in patients with chronic periodontitis. The primary objective is to assess changes in key periodontal parameters including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI) over a defined follow-up period. Participants will be randomly assigned to two groups: one receiving standard NSPT alone and the other receiving NSPT combined with subgingival application of I-PRF. The study seeks to determine whether the adjunctive use of I-PRF can enhance periodontal healing and improve clinical outcomes compared to conventional therapy alone.
详细描述
This randomized controlled clinical trial is designed to assess the clinical efficacy of non-surgical periodontal therapy (NSPT) with and without the adjunctive use of injectable platelet-rich fibrin (I-PRF) in the management of chronic periodontitis. Periodontal disease is a multifactorial inflammatory condition characterized by progressive destruction of the supporting structures of the teeth. NSPT, primarily through scaling and root planing (SRP), remains the gold standard for initial therapy. However, the regeneration of periodontal tissues following NSPT can be limited, especially in moderate to advanced cases.
Injectable PRF (I-PRF) is a second-generation autologous platelet concentrate prepared without anticoagulants, offering a fluid formulation rich in platelets, leukocytes, and growth factors. Its injectable nature allows subgingival delivery, promoting enhanced wound healing and soft tissue regeneration. This study aims to investigate whether adjunctive use of I-PRF following SRP can provide superior clinical outcomes compared to SRP alone.
Participants diagnosed with generalized chronic periodontitis, presenting with probing depths ≥5 mm in at least two quadrants, will be enrolled. Subjects will be randomly allocated into two groups:
Test Group: Undergo NSPT (scaling and root planing) followed by subgingival injection of I-PRF at selected sites.
Control Group: Undergo NSPT alone without any adjunctive treatment.
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 (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Medically free, Non-smokers, Stage III Periodontitis Patients, Probing depth <5mm
排除标准
- •Systemic disease, Smoking, Pregnancy, History of Chemotherapy, Radiotherapy
研究组 & 干预措施
Non-surgical Periodontal Therapy
Non-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes
干预措施: non-surgical periodontal therapy (Procedure)
Non-surgical Periodontal Therapy + Injectable Platelet Rich Fibrin
Non-surgical Periodontal Therapy using ultrasonic scaling and root debridement using Gracey Curettes with adjunctive use of Injectable Platelet Rich Fibrin
干预措施: non-surgical periodontal therapy + I-PRF (Procedure)
结局指标
主要结局
Clinical attachment Gain
时间窗: 3 months
the change in the distance from the Cemento-Enamel Junction to the base of the periodontal pockets
次要结局
- Bleeding on Probing(3 months)
- Probing Depth Reduction(3 months)
研究者
Mohamed Atef Abd El Moneium
Assistant Professor of Periodontics
Cairo University