Evaluation of clinical efficacy of sub-gingivally delivered Propolis Nanoparticle as an adjunct to non-surgical periodontal therapy in patients with stage 2 and stage 3 periodontitis: a split mouth randomized controlled trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- To evaluate the clinical efficacy of sub-gingivally delivered Propolis Nanoparticles as an adjunct to non-surgical periodontal therapy in patients with stage 2 and stage 3 periodontitis: a split mouth randomised controlled trial.
研究概览
简要总结
This is a randomized clinical split mouth study to evaluate the clinical efficacy of sub-gingivally delivered propolis nanoparticles as an adjunct to scaling and root plaing in patients with stage 2 and stage 3 periodontitis.
Study design :
Group 1 consisting of 25 subjects with stage 2 and stage periodontitis, receiving propolis nanoparticles as a local drug delivery
Group 2 consisting of 25 subjects with stage 2 and stage 3 periodontitis, receiving placebo [i.e. saline] as a local drug delivery
The clinical parameters [ plaque index, gingival index, relative attachment loss, probing pocket depth , sulcular bleeding index]will be evaluated at baseline, one month and three month period.
The data obtained will be entered in Microsoft excel spread sheet and will be further analyzed with the help of SPSS software ( version 17.0, IBM.USA)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Both male and female patients with stage 2 or stage 3 periodontitis in at least 2 teeth in contralateral quadrants.2.Age group between 18-60 years with good systemic health.
- •Minimum 20 teeth should be present in the mouth of patients.
- •4.Patients with no history of allergies.
排除标准
- •1.Patients suffering from any known systemic diseases.2.Smokers and alcoholic patients.3 Pregnancy or lactating female patients.4.Patients who have received surgical or nonsurgical periodontal therapy in last 3 months prior to the baseline visit.5.• Patients who have allergic to propolis products.
结局指标
主要结局
To evaluate the clinical efficacy of sub-gingivally delivered Propolis Nanoparticles as an adjunct to non-surgical periodontal therapy in patients with stage 2 and stage 3 periodontitis: a split mouth randomised controlled trial.
时间窗: Baseline | one month after local drug delivery | Three month after local drug delivery
次要结局
- To evaluate improvement in plaque index, gingival index, sulcular bleeding index, probing pocket depth and relative attachment loss(Plaque index, gingival index, sulcular bleeding index, probing pocket depth and relative attachment loss will be evaluated at baseline, one month and three month.)
研究者
Dr Ankit Desai
Terna dental college and Hospital