The Effect of Mouthwashes Containing Pomegranate Peel, German Chamomile or Their Combination in the Treatment of Gingivitis
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical assessment for the gingival index (GI)
研究概览
简要总结
The aim of this study is to compare clinically and biochemically the effect of herbal mouthwashes containing German chamomile and pomegranate peel extracts individually and as a mixture to chlorohexidine mouthwash in the treatment of gingivitis. The response will be assessed clinically and by suitable biochemical parameters.
详细描述
- Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine and Faculty of Dentistry, Alexandria University
- All participants should agree to take part in this clinical study and will provide informed consent.
- Sixty plaque induced gingivitis patients ,will be recruited from Faculty of Dentistry, Alexandria University.
- The 60 participants will be randomly assigned into 5 groups. Group 1: Patients will be managed by scaling. Group 2: Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.
Group 3: Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily.
Group 4: Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
Group 5: Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily. 5. All patients will be submitted to:
- Full patient history and clinical examination.
- Gingival index will be measured
- Saliva samples will be obtained in order to conduct ELISA for the selected biomarkers.
- Different mouthwashes will be provided to patients.
- Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
- Results, conclusion, discussion and recommendations will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 25-50
- •Patients with plaque induced gingivitis.
排除标准
- •Patients with systemic diseases (diabetes, leukemia, anemia)
- •Pregnant females
- •Patients receiving orthodontic treatment
研究组 & 干预措施
Scaling
12 patients will be managed by scaling only
干预措施: Scaling (Procedure)
Scaling and Chlorohexidine mouthwash
Patients will be managed by scaling and will use 0.12%% chlorohexidine mouthwash in a dose of 15 ml twice daily.
干预措施: Scaling and Chlorohexidine mouthwash (Drug)
Scaling and Chamomile extract mouthwash
Patients will be managed by scaling and will use 5% chamomile extract mouthwash in a dose of 15 ml twice daily.
干预措施: Chamomile extract mouthwash (Drug)
Scaling and Pomegranate peel extract mouthwash
Patients will be managed by scaling and will use 5% pomegranate peel extract mouth wash in a dose of 15 ml twice daily.
干预措施: Pomegranate peel extract mouth wash (Drug)
Scaling and Chamomile extract mixed with Pomegranate peel extract mouthwash
Patients will be managed by scaling and will use a combination of 5% chamomile extract and pomegranate peel extract mouthwash in a dose of 15 ml twice daily.
干预措施: Combination of 5% chamomile extract and pomegranate peel extract mouthwash (Drug)
结局指标
主要结局
Clinical assessment for the gingival index (GI)
时间窗: 15 days
The gingival index will measured before treatment, 7 days, and 15 days after treatment respectively.
次要结局
- Measurement of TNF-α saliva level(15 days)
- Measurement of IL1β saliva level(15 days)