Comparative Evaluation of Local Injectable Platelet Rich Fibrin and Hyaluronic Acid as Adjunctive to Non Surgical Periodontal Therapy: a Randomized Placebo Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 主要终点
- Clinical attachment level (CAL)
研究概览
简要总结
Clinical evaluation of local subgingival application of injectable platelet-rich fibrin ( i-PRF ) for chronic periodntitis as adjunctive to non surgical therapy and compare it with hyaluronic acid.
120 periodontal patients will receive a scaling and root planing ( non surgical periodontal therapy). Equal number of patients will receive subgingival application of i-PRF, hyaluronic acid or placebo gel as the adjunction to non surgical therapy.
详细描述
The aim of the study is to evaluate and compare the clinical efficacy of subgingival application of i-PRF and hyaluronic acid gel as adjunctive to non-surgical periodontal therapy. 120 periodontal patients will receive traditional mechanical supra and subgingival scaling and root planing. Patients were randomly allocated in three groups. Group 1, 2 and 3 will receive subginigval application of placebo, hyaluronic acid gel and i prf respectively. Clinical parameters will be evaluated: plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), clinical attachment level (CAL), gingival recession (GR). Clinical measurements will be performed at baseline, 1 month and at 3 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients are in general good health.
- •Patients having minimum of 20 permanent teeth.
- •They have not taken medication known to interfere with periodontal tissue health or healing in the preceding 6 months.
- •Presence of periodontal pockets (≥5 mm) and clinicala ttachment level > 5 mm.
排除标准
- •Immunosuppressive systemic diseases (like cancer, AIDS, diabetes etc.)
- •Clotting and Hematological disorders
- •Patients with grade III mobility.
- •Patients with smoking and alcohol consuming habit.
- •Pregnant and lactating female.
- •Medications influence on the gingival and periodontal tissues (like calcium channel blockers, or Long-term steroid use)
- •The teeth with poor filling and ill fitted restorations
研究组 & 干预措施
Test group 2
injectable prf
干预措施: Platelet rich fibrin (Biological)
Negative control
Placebo gel
干预措施: Placebo gel (Other)
Test group 1
Hyaluronic acid gel
干预措施: Hyaluronic acid gel (Drug)
结局指标
主要结局
Clinical attachment level (CAL)
时间窗: 3 Months
Measure as the change in distance from the cementoenamel junction to the bottom of the gingival sulcus by using a periodontal probe (UNC 15 "University of North Carolina")
次要结局
- Probing pocket depth(3 Months)
研究者
ASHISH AGARWAL
Clinical professor, institute of dental sciences, bareilly
Institute of Dental Sciences, Bareilly, Uttar Pradesh, India