Clinical and Microbiological Efficacy of Systemic Ayurvedic Immunomodulator Septilin in the Treatment of Chronic Periodontitis-- A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Attachment Level (CAL)
研究概览
简要总结
The present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP)
详细描述
OBJECTIVE
The present clinical trial was designed to investigate the clinical and microbiological effectiveness of systemic ayurvedic immunomodulator Septilin as an adjunct to scaling and root planing (SRP) in the treatment of chronic periodontitis (CP).
DESIGN: Sixty five subjects presenting at least twelve teeth with probing depth (PD) ≥4 mm were selected. 33 subjects were randomly assigned to full-mouth SRP + Septilin (group 1) and 32 subjects were assigned to full-mouth SRP + Placebo (group 2). The clinical outcomes evaluated were plaque index (PI), gingival index (GI), clinical attachment level (CAL), PD and % of sites with bleeding on probing (%BOP) at baseline (B\L), 10 days, 1, 3 and 6 months interval and percentage of sites positive for A. actinomycetemcomitans, P. gingivalis and T. forsythia were recorded at B/L, 3 and 6 months using polymerase chain reaction.
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 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 30 to 50 years
- •atleast 12 scorable teeth with a probing depth (PD) ≥ 4 mm not including third molars
- •teeth with orthodontic appliances bridges, crowns, or implants
- •radiographic evidence of bone loss.
排除标准
- •pregnancy or lactation
- •systemic diseases like diabetes mellitus, immunocompromised patients
- •systemic antibiotics taken within the previous 6 months
- •use of non-steroidal anti-inflammatory drugs
- •sub-gingival SRP or surgical periodontal therapy in the previous year.
研究组 & 干预措施
Septilin Group
Subjects in septilin group received Septilin tablets (Septilin tablets, Himalaya Drug Company, India), 500 mg of 2 tablets to be taken thrice daily for 7 days after scaling and root planing
干预措施: Scaling and root planing, and Septilin for 7 days (Drug)
Placebo Group
Subjects in placebo group received Placebo tablets thrice daily for 7 days after Scaling and root planing
干预措施: Scaling and root planing, and Placebo drug for 7 days (Drug)
结局指标
主要结局
Clinical Attachment Level (CAL)
时间窗: Gain in CAL from Baseline to 6 month
The primary outcome of the study was gain in CAL from Baseline to 6 month
次要结局
- PIaque Index (PI), Gingival Index (GI), Probing Depth (PD), % Bleeding on Probing and reduction in number of sites positive for each microbial species(The differences in PI, GI, PD, %BOP between two groups and reduction in number of sites positive for each microbial species from Baseline to 6 month)
研究者
Dr. A R Pradeep
Professor
Government Dental College and Research Institute, Bangalore