Evaluation of Anti-plaque and Anti-inflammatory Effects of Green Tea and Salvadora Persica L. in Patients With Gingivitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- change in plaque index
研究概览
简要总结
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection.The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX).chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .The objective of this study was to investigate the efficacy of the combination of Gt aqueous extract and Sp aqueous extract in reducing plaque buildup and gingivitis for 4 weeks duration.
详细描述
Gingivitis is an inflammatory condition of the gingival tissue, most commonly caused by bacterial infection. Unlike periodontitis, there is no attachment loss and therefore no migration of the junctional epithelium. The condition is restricted to the soft-tissue area of the gingival epithelium and connective tissue.Gingivitis is caused by the microbial plaque deposits located in or close to the gingival sulcus).
The plaque control is considered the most important preventive factor concerning caries, gingivitis, and periodontitis Mechanical means of plaque control, e.g. tooth brushing, flossing and use of other mechanical devices are the most commonly used methods. However, ideal plaque control solely by mechanical means requires a significant effort and is difficult to achieve.This has led to the introduction of chemical methods of plaque control using antimicrobial agentsMore specifically, chemotherapeutic agents with antimicrobial properties, such as 0.12% chlorhexidine (CHX), have been proposed as an adjunct to the standard oral hygiene protocol. chx has side effects encourage the need to develop alternative mouthwashes with similar efficacy but without these issues.
Hence the mouthwash enriched with a combination of aqueous extracts of Salvadora persica L. and green tea used as a substitution to CHX with minimal side effects .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 55 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged more than 15 years-old who will volunteer to participate.
- •Participants who were apparently systemically healthy.
- •Not taking antibiotic and anti-inflammatory drugs in the last three months
- •Patients having generalized gingivitis with intact periodontium in which they have more than 30% bleeding sites with no PPD >3 mm with no clinical attachment loss according to criteria proposed by
排除标准
- •Those with history of systemic chronic disease, immunocompromised patients.
- •Those currently using any mouthwash.
- •Those on antibiotic therapy, anti-inflammatory medications or NSAID during the study and at the last 3 months before the study.
- •Those having a history of hypersensitivity to any product used in the present study.
- •Those having periodontitis.
- •Those who smoker or alcoholism.
- •handicapped patient or patients with limited manual dexterities.
- •pregnant , lactating women or taking contraceptive pills.
- •Subjects wearing orthodontic appliances or removable dentures.
- •patients unwilling to participate in study.
研究组 & 干预措施
co.mouthwash
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
干预措施: co.mouthwas (Drug)
Kin mouthwash
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
干预措施: Kin (Other)
Distilled water
15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min
干预措施: Distilled water (Other)
结局指标
主要结局
change in plaque index
时间窗: 0-30 days
Mean amount plaque between different comparators. Mean amount plaque between different comparators as anti-plaque agent after rinsing with different comparators using means of modified quigely hein plaque index\[ Turesky ,1970
次要结局
- Mean relative change in cytokine interleukin-6 level in salivary Fluid(0-30 days)
- Change in BOP score(0-30 Days)
- change in Gingival index(0-30 days)
研究者
Aliaa Saeed Salman
principal investigator
University of Baghdad