Evaluation and Comparison of Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus MucofibroTM V/S Scaling and Root Planing alone: A one month Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- 1. To evaluate the efficacy of oral antioxidant supplement as an adjunt to scaling and root planing in the non-surgical management of Periodontal Disease in Tobacco Users
研究概览
简要总结
| AIM- To evaluate and compare the Non-surgical |
| Management of Periodontal Disease in Tobacco Users using Scaling and Root |
| Planing plus MucofibroTM V/S Scaling and Root Planing alone. |
|OBJECTIVES-
1. To evaluate the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus oral antioxidant supplement.
2. To evaluate the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing alone.
3. To compare the Non-surgical Management of Periodontal Disease in Tobacco Users using Scaling and Root Planing plus oral antioxidant supplement V/S Scaling and Root Planing alone.
The study will evaluate the following parameters- Oral Hygiene Index Simplified, Plaque index, Gingival index, Clinical Attachment level, Pocket probing depth.
These parameters will be evaluated at baseline and after 15 days. Based on the results obtained it will be evaluated whether the use of oral antioxidant supplements can provide any additional benefit in improvement in clinical parameters in tobacco users.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients free from systemic diseases between the age group of 18-70 years, who signed the consent form, having a habit of tobacco consumption and undergoing non-surgical periodontal therapy were a part of this clinical trial.
排除标准
- •Patients giving a history of undergoing surgical periodontal treatment in the past 6 months, as well as pregnant or lactating women, were excluded from the study.
结局指标
主要结局
1. To evaluate the efficacy of oral antioxidant supplement as an adjunt to scaling and root planing in the non-surgical management of Periodontal Disease in Tobacco Users
时间窗: Baseline and after 15 days
2. To evaluate the efficacy of scaling and root planing in the non-surgical management of Periodontal Disease in Tobacco Users
时间窗: Baseline and after 15 days
3. To compare the efficacy of oral antioxidant supplement as an adjunt to scaling and root planing versus scaling and root planing alone in the non-surgical management of Periodontal Disease in Tobacco Users
时间窗: Baseline and after 15 days
次要结局
- The clinical parameters evaluated were- Oral Hygiene Index- Simplified(OHI-S), Plaque Index(PI), Gingival Index(GI), Modified Sulcular Bleeding Index (M-SBI), Pocket probing depth (PPD) and Clinical Attachment Level (CAL).(Baseline and after 15 days)
研究者
Dr. Saurabh Prithyani
Terna Dental College