Abti-plaque, Anti-gingivits and Cytotoxic Effect of Chlorhexidine and Sesamum Indicum Oil-pulling- A Clinico-cytological study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- there is expected to be no significant difference between chlorhexidine gluconate and sesame oil pulling in in removal of plaque efficacy and gingivitis from baseline to 21 days after use
研究概览
简要总结
Chlorhexidine gluconate (CHX) is widely recognized as the gold standard for chemical plaque control; however, its use is associated with certain side effects. Alternatively, sesame oil (Sesamum indicum) has shown promising results in reducing plaque through the traditional method of oil pulling. Despite its increasing popularity, limited data exists on the comparative cytotoxic effects of CHX and sesame oil. This study aims to evaluate and compare the anti-plaque, anti-gingivitis, and cytotoxic effects of CHX mouthwash and Sesamum indicum oil pulling in individuals with chronic generalized gingivitis. A double-blind clinical trial will be conducted in the Department of Public Health Dentistry, Government Dental College and Hospital, Ahmedabad, over a period of 3–4 months. A total of 75 participants will be randomly divided into three groups: CHX mouthwash, sesame oil pulling, and control. Clinical parameters will be assessed using the Turkesky Gilmore Glickman modification of the Quigley-Hein Plaque Index and the Loe and Silness Gingival Index at baseline and after 21 days. Cytological evaluation will be done through buccal mucosa cell collection and micronucleus assay to assess genotoxic effects. Statistical analysis will be performed using SPSS v27, with a significance level set at 5%. It is expected that while CHX may demonstrate superior efficacy in reducing plaque and gingival inflammation, it may also exhibit higher cytotoxicity compared to Sesamum indicum oil.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects above 18 years of age having chronic gingivitis.
- •2.Subjects free from any form of tobacco and alcohol consumption habit.
- •3.Subjects having no systemic diseases.
- •4.Subjects who are willing to participate by giving the informed consent.
排除标准
- •1.Subjects having any oral pathological conditions.
- •2.Subjects who undergone any radio diagnostic examinations in the last six months.
- •3.Pregnant and lactating mothers.
- •4.Subjects who undergone any periodontal surgery in the last six month 5.Subjects having hypersensitivity to CHX and Sesamum indicum oil.
结局指标
主要结局
there is expected to be no significant difference between chlorhexidine gluconate and sesame oil pulling in in removal of plaque efficacy and gingivitis from baseline to 21 days after use
时间窗: from baseline to 21 days after use
次要结局
- there is expected to be significant difference between chlorhexidine gluconate & sesame oil pulling in removal of plaque efficacy & gingivitis(from baseline to 21 days after use outcome will be accessed)