Anti-Inflammatory Efficacy of Ginger Containing Dentifrice in the Control of Biofilm Induced Gingivitis: a 3 Months Randomized Parallel Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Change in Gingival index
研究概览
简要总结
The goal of this clinical trial is to test efficiency of using toothpaste containing (Ginger) over a period of three month to control on gingival inflammation and plaque accumulation through measuring the clinical periodontal parameters (Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-Hein Plaque Index (mQHPI ) in comparison with Colgate total toothpastes in patients with biofilm induced gingivitis.
详细描述
Objectives:
- Measuring the clinical periodontal parameter (gingival index) and salivary cytokine IL-1β and superoxide dismutase SOD over a period 3 months before and after using Capitano (ginger containing) and Colgate total toothpastes for patients with gingivitis.
- Measuring the clinical periodontal parameter ((Gingival Index (GI), Bleeding on probing (BOP) and modified Quigley-HeinPlaque Index (mQHPI )) over a period 3 months before and after using Capitano (ginger containing) and Colgate total toothpastes for patients with gingivitis by ELISA.
- correlation between ( Interleukin 1 beta and SOD) and clinical periodontal parameters
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, Investigator)
盲法说明
The products will be packaged in such a way that they are not recognizable neither by the operator, nor by the patient. Each package will be assigned a number that in turn will refer to the type of the product. The association between the number and type of the product will be collected by another operator according to the association carried out by a dedicated software. The operator who will deliver the product will be informed about the type only at the end of the treatment.
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged 20-35 who will volunteer to participate.
- •Apparently good general health.
- •Patients with gingivitis (having ≥30% bleeding sites with no PPD >3 mm, intact periodontium and no loss of periodontal attachment).
- •Those with a minimum of 20 natural teeth.
排除标准
- •Those with chronic disease, immunocompromised patients, pregnant, on contraceptive and lactating women.
- •Those currently using any mouthwash.
- •Those on antibiotic therapy and anti-inflammatory medications during the study and at the last 2 months before the study.
- •Those having a history of hypersensitivity to any product used in the present study.
- •Those with a recent tooth extraction.
- •Those having periodontitis.
- •Those who smoker or alcoholism.
- •Those with extensive untreated dental caries, diseases of hard and soft palate and subjects wearing orthodontic appliances, removable dentures, implant, crown and bridge or presenting with abnormal salivary flow.
研究组 & 干预措施
Capitano zenzero toothpaste
Participants will be given the test interventions, Capitano zenzero toothpaste, and will be asked to brushing teeth with this product for two minutes twice per day and will be instructed to refrain from eating and drinking for 30 min after rinsing.
干预措施: Capitano zenzero toothpaste (Drug)
Colgate total toothpaste
Participants will be given the test interventions, Colgate total toothpaste, and will be asked to brushing teeth with this product for two minutes twice per day and will be instructed to refrain from eating and drinking for 30 min after rinsing.
干预措施: Colgate total toothpaste (Drug)
结局指标
主要结局
Change in Gingival index
时间窗: 0 ,3 months
Subjects will undergo the measurement of gingival index according to Loe \& Silness, designed to assess the severity and quality of gingival inflammation in an individual or population. The gingival inflammation is assessed on the basis of color, consistency and bleeding on probing. The gingiva surrounding the tooth is assessed at four sites: mesio-facial papilla, facial marginal gingiva, disto-facial papilla and lingual marginal gingiva. Data will be collected based on four possible clinical conditions: 0=Normal gingiva1=Mild Inflammation-Slight change in color, Slight odema. No bleeding on probing2=Moderate inflammation-redness,odema and glazing. Bleeding on probing 3=Sever inflammation-marked redness and edema.Ulceration.Tendency to spontaneous bleeding.
Mean relative changes in Interleukin 1 beta level in salivary Fluid.
时间窗: 0 ,3 months
Mean relative changes in Interleukin 1 beta level in salivary fluid after brushing with different comparators from baseline at 3 months.
Mean relative changes in superoxide dismutase SOD level in salivary Fluid.
时间窗: 0 ,3 months
Mean relative changes in superoxide dismutase SOD level in salivary fluid after brushing with different comparators from baseline at 3 months.
次要结局
- Mean amount plaque between different comparators.(0 ,3 months)
- Changes in BOP score(0 ,3 months)
研究者
Zainab Zuhair Alalawi
Principal Investigator
University of Baghdad