Evaluation of the Efficacy of an herbal mouthwash in the Management of Chronic Periodontitis – a Randomized controlled clinical trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Differences in mean gingival bleeding
研究概览
简要总结
The aim of the studyis to evaluate the efficacy of an herbal mouthwash in the Management of ChronicPeriodontitis in comparison with chlorhexidine mouthwash. 60 patients withchronic periodontitis will be selected and they will be randomly divided into 2groups. Detailed periodontal examination will be done in all the patients followedby scaling and rootplaning. Group I will be instructed to use herbal mouthwashprepared by Kottaykkal aryavaidya shalaaccording to the composition described in patent (United States patent application US 13/883,551. 2013 Sep19) twice daily for 2 weeks. Group II will be instructed to use chlorhexidinemouthwash, which is considered as the gold standard mouthwash. Reevaluation willbe done after 2 weeks to evaluate the efficacy of the mouthwash in reducinggingival inflammation and plaque accumulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Systemically healthy patients diagnosed with chronic generalized periodontitis.
- •2.Presence of gingival inflammation, GI≥ 2 3.≥ 20naturalteeth 4.Probing depth (PD) ≥ 5mm in> 30 % of sites 5.CAL ≥ 3mm in> 30% of sites •Radiographic evidence of generalized alveolar bone loss>50% •Those willing to participate in the study.
排除标准
- •ïƒ˜Patients with systemic diseases or other conditions that could influence the periodontal status; Patients who are currently under any medication and who have taken antibiotics or anti-inflammatory drugs for the past 3 months orthodontic devices, extended prosthetic ï¬xed devices, removable partial dentures, or overhanging restorations regular use of chemotherapeutic antiplaque/anti gingivitis products periodontal treatment performed within 6 months before study initiation Pregnant and lactating females Aggressive periodontitis Current smokers.
结局指标
主要结局
Differences in mean gingival bleeding
时间窗: Baseline to 14 days
次要结局
- Reduction in plaque,pocket depth(Baseline to 14 days)