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
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- change in bleeding on probing
研究概览
简要总结
The aim of the study is to evaluate the efficacy of an herbal mouthwash in the Management of Chronic Periodontitis in comparison with chlorhexidine mouthwash. 120 patients with chronic periodontitis will be selected and they will be randomly divided into 4 groups. Detailed periodontal examination will be done in all the patients followed by scaling and rootplaning. Group I will be instructed to use liquid form of herbal mouthwash, Group II will be instructed to use 30g active ingredient of drug in powder form diisolved in water , Group III will be instructed to use 50 g whole extract of herbal drug dissolved in water and Group IV will be instructed to use chlorhexidine mouthwash, which is considered as the gold standard mouthwash. Herbal drug in liquid and powder form will be prepared by Ceego Labs Pvt. Ltd, Chennai according to the composition described in patent (United States patent application US 13/883,551. 2013 Sep 19). the application of mouthwash is recommended twice daily for 2 weeks. Reevaluation will be done after 2 weeks to evaluate the efficacy of the mouthwash in reducing gingival inflammation and plaque accumulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Investigator 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
- •â€¢Systemically healthy patients diagnosed with chronic generalized periodontitis.
- •â€¢Presence of gingival inflammation, GI≥ 2 •≥ 20naturalteeth •Probing depth (PD) ≥ 5mm in> 30 % of sites •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
- •Patients with systemic diseases or other conditions that could influence the periodontal status 2.Patients who are currently under any medication and who have taken antibiotics or anti-inflammatory drugs for the past 3 months 3.orthodontic devices, extended prosthetic ï¬xed devices, removable partial dentures, or overhanging restorations 4.regular use of chemotherapeutic antiplaque/anti gingivitis products 5.periodontal treatment performed within 6 months before study initiation 6.Pregnant and lactating females 7.Aggressive periodontitis 8.Current smokers.
结局指标
主要结局
change in bleeding on probing
时间窗: baseline and 2 weeks after scaling and root debridement
次要结局
- plaque accumulation(baseline and 2 weeks after scaling and root debridement)
- pocket depth reduction(baseline and 2 weeks after scaling and root debridement)