A Comparative Evaluation of Subgingivally Delivered Chlorhexidine, Silk Fibroin and Combination of Fibroin and Chlorhexidine as Local Drug Delivery in Periodontitis - A Randomized Control Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 主要终点
- Probing pocket Depth (PPD)
研究概览
简要总结
The current study is a prospective randomised split mouth study to evaluate the effect of Silk fibroin as drug delivery system while simultaneously assessing the efficacy of silk fibroin in comparison to chlorhexidine.
详细描述
Fifteen healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, procedure involved, potential benefits and risks associated with procedure and written informed consent were obtained from all patients.All the patients underwent scaling and root planing.
Following randomization, the site will be assigned to one of the three study groups.
- Group I (SRP+ Silk Fibroin)
- Group II (SRP+ Chlorhexidine)
- Group III (SRP+ Combination of Fibroin and Chlorhexidine) Periodotal pack was placed and patient was recalled after 21days, 1 month and 3 month for the follow up.
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
- None
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patient with age between 30-50 years.
- •Patients with stage I/ II with Grade A/ B periodontitis according to 2017 World workshop classification of periodontal disease will be considered.
- •Patients with localized periodontal pockets.
- •Patients willing to participate in the study.
排除标准
- •Patients with known systemic diseases.
- •Non complaint patients.
- •Patients who received any surgical or nonsurgical therapy 6 months before the start of the study.
- •Pregnant or lactating females.
- •Use of systemic antibiotics in the past 6 months.
研究组 & 干预措施
Group I - Silk Fibroin
test group 1 is treated with silk fibroin
干预措施: silk fibroin (Biological)
Group II -Chlorhexidine
test group 2 is treated with chlorhexidine
干预措施: Chlorhexidin (Drug)
Group III - Combination of Fibroin and Chlorhexidine
test group 3 is treated with combination of silk fibroin and chlorhexidine
干预措施: combination of silk fibroin and chlorhexidine (Biological)
结局指标
主要结局
Probing pocket Depth (PPD)
时间窗: 3 months
measured using a UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA
Relative attachment level (RAL)
时间窗: 3 months
measured by placing the acrylic stent on the selected teeth using UNC-15 probe (university of North Carolina-15 periodontal probe- Hu-Friedy, Chicago, IL, USA)
次要结局
- Plaque Index(3 months)
- Modified Sulcus Bleeding Index(3 months)
- Gingival index(3 month)