Efficacy of Subgingivally Placed Amnion Membrane With and Without Taurine as an Adjunct to Scaling and Root Planing in the Treatment of Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- TNF-α level
研究概览
简要总结
45 sites in 15 patients with periodontal pockets ≥ 5mm were selected. These selected sites were divided into 3 groups as Group A, B and C.
详细描述
Group A (Control): 15 sites received only SRP, Group B: 15 sites received SRP with subgingival placement of amnion membrane, Group C: 15 sites received SRP with subgingival placement of Amnion membrane hydrated with Taurine.
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
- Double (Participant, Outcomes Assessor)
盲法说明
patients and statistician are masked about treatment modality
入排标准
- 年龄范围
- 29 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Systemically healthy patients with sites showing probing depth (PD) ≥ 5mm, clinical attachment level (CAL) ≥ 4 mm, and vertical bone loss ≥ 3 mm on intraoral periapical radiographs with no history of periodontal therapy or use of antibiotics in the preceding 6 months
排除标准
- •Any systemic disease that could influence the outcome of periodontal therapy.
- •Smokers, alcoholics & patients with other adverse habits.
- •Pregnant or nursing women.
- •Any known allergy or hypersensitivity to any product used in the study.
- •Patients on long term systemic therapy (antibiotics, anti-inflammatory and any other).
研究组 & 干预措施
Group A
15 sites received only scaling and root planing
干预措施: Scaling and root planing (Procedure)
Group B
15 sites received scaling and root planing with subgingival placement of amnion membrane
干预措施: Scaling and root planing (Procedure)
Group B
15 sites received scaling and root planing with subgingival placement of amnion membrane
干预措施: Amnion membrane (Biological)
Group C
15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine
干预措施: Scaling and root planing (Procedure)
Group C
15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine
干预措施: Amnion membrane (Biological)
Group C
15 sites received scaling and root planing with subgingival placement of amnion membrane hydrated with Taurine
干预措施: Taurine (Drug)
结局指标
主要结局
TNF-α level
时间窗: changes from baseline to 45 days
TNF-α level in Gingival crevicular fluid
Probing pocket depth (PPD)
时间窗: changes from baseline to 45 days
Probing pocket depth at selected site
Relative attachment level (RAL)
时间窗: changes from baseline to 45 days
Relative attachment level from stent to base of the pocket
次要结局
- Gingival index (GI)(changes from baseline to 45 days)
- Plaque index (PI)(changes from baseline to 45 days)
- Bleeding on probing (BOP)(changes from baseline to 45 days)
研究者
DR SURINDER SACHDEVA
PROFESSOR
Maharishi Markendeswar University (Deemed to be University)