Comparative Efficacy of Local Subgingival Application of Injectable Platelet Rich Fibrin and (-)-Epigallocatechin Gallate Gel as an Adjunct to Scaling and Root Planing: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Clinical Attachment level (CAL)
研究概览
简要总结
Aim of the study
Aim of this study is to evaluate theclinical efficacy of local subgingival application of i-prf and EGCG gel as adjunct to SRP on periodontal clinical parameters of stage II & III periodontitis patientsas compared to SRP alone.
Material and methods:
Study design: Randomized controlled clinical trial
Clinical protocol:1. Informed consent to be obtained from the patients who wish to participate in the study2. Demographic characteristics such as age, sex, and medical history to be recorded3. Clinical parameters will be recorded at baseline, 3 months and 6 months. The following clinical parameters will be evaluated: i. Plaque index (PII) by Silness and Loe 1964 ii. Percentage of bleeding sites (Dichotomousscoring) iii. Probing pocket depth (PPD)- measured at six sites per tooth using UNC 15 periodontal probe ,iv. Clinical attachment level (CAL)- measured at six sites per tooth using UNC 15 periodontal probe and occlusal splint v. Gingival Margin Level (GML)- measured from CEJ to crest of marginal gingivaThe data obtained will bestatistically analysed
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 35.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients within the age of 35 to 60 years 2.Presence of minimum of 16 natural teeth excluding 3rd molars 3.Systemically healthy patients with periodontitis (Stage II, III) clinically diagnosed based on 2017 World Workshop on the Classification of Periodontal and Peri- implant diseases and conditions.[12] Periodontitis patients with Bleeding on probing ≥ 40% of teeth, clinical attachment loss ≥ 3mm in more than 30% of the sites and probing pocket depth ≥5 mm with at least 6 teeth and radiographic bone loss ranging from coronal to middle third or beyond.
排除标准
- •1.Patients with any systemic diseases 2.Patients with allergy to green tea or product of green tea.
- •3.Patients with history of periodontal therapy within past 6 months 4.Patients with history of antibiotic intake within past 3 months 5.Patients with history of anti-inflammatory drug therapy within 3 months 6.Furcation involvement 7.Pregnancy or lactation 8.Current or former smokers 9.Patients with any intra oral lesions.
结局指标
主要结局
Clinical Attachment level (CAL)
时间窗: At baseline, | 3 months | 6 months
Gingival Margin Level(GML)
时间窗: At baseline, | 3 months | 6 months
Probing Pocket depth(PPD)
时间窗: At baseline, | 3 months | 6 months
次要结局
- Bleeding on Probing(BOP)(Plaque Index(PI))