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临床试验/NCT03790904
NCT03790904已完成2 期

Evaluation of Anti-plaque Effect of a Mouthwash Composed of Salvadora Persica L. and Green Tea: a 4days Randomized Controlled Crossover Clinical Trial

University of Baghdad2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2019年1月10日最近更新:
适应症
干预措施

试验速览

阶段
2 期
状态
已完成
入组人数
15
试验地点
2
主要终点
Mean amount plaque between different comparators

研究概览

简要总结

Periodontal diseases and caries are essentially initiated and progressed by accumulation of dental plaque. Thus, daily effective plaque control is valuable as a preventive measure and maintaining oral health. Mechanical plaque control is important but has limitations; therefore, an adjunctive chemical plaque control such as mouthwash is helpful. Various medicinal plant-derived galenicals might be used as safe and stable alternatives to synthetic mouthwashes. For example, a combination of Salvadora persica L. (Sp) root sticks and green tea (Gt) aqueous extract has been found to reduce plaque accumulation over 24 hours. Moreover, these extracts were reported to have anti-microbial activity against many oral bacteria. 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 for 4 days duration.

详细描述

Dental plaque is the soft mass formed on oral surfaces including tooth surfaces. It composed of many species of which are commensal and other are pathogenic. The buildup of dental plaque starts by adhesion of floating bacteria, primary colonizers, in saliva onto oral surfaces such as tooth surfaces. Consequently, after adhesion, these primary bacteria provide adhesion sites for secondary plaque colonizers and the plaque buildup continues to achieve a mature dental plaque.

The mature dental plaque initiates host immune response by its bacterial content or its toxins in the adjacent gingival tissues. Periodontal health is assumed to be in a state of balance when the host immune response resolves the bacterial challenges. In other scenario, the host immune response fails to overcome invader bacteria or their toxins leading to chronicity of aberrant immune responses. Thus, periodontal diseases and caries may be developed due to imbalance between dental plaque accumulation and host defense. For that reason, dental plaque control is essential as preventive measure for good oral health.

Mechanical plaque control including tooth brushing and interdental aids is essential for preserving oral health. However, efficient mechanical control is time consuming and needs high manual dexterity and compliance. Therefore, chemical plaque control such as mouthwashes might be useful as adjunctive to mechanical control. Chlorohexidine mouthwash is the best-known mouthwash serving that purpose despite its side effects including tooth discoloration and bitter taste.

Salvadora persica L. (Sp) root sticks and green tea (Gt), leafs of Camellia sinensis, aqueous extracts were reported to exert anti-microbial activity against many oral bacteria. A combination (Co.) of Gt aqueous extract and Sp aqueous extract at a specific concentration (patented, IP 2015704777) was found to exhibit significant synergistic anti-bacterial and anti-adherence efficacy against primary plaque colonizers in vitro. This Co. as a mouthwash was reported to significantly reduce plaque accumulation comparing to chlorhexidine in vivo for a period of 24 hours (NCT02624336 in December 3, 2015).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 23 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Participants should be medically healthy.
  • Participants should have more than 20 teeth.

排除标准

  • Participants who have active cavity caries and/or periodontal disease.
  • Participants who have ongoing orthodontic treatment.
  • Participants who have been on antibiotics within the past 4 months.
  • Participants who require prophylactic antibiotic coverage.
  • Participants who have been on systemic or topical non-steroidal anti-inflammatory drugs for the past 4 months.
  • Participants who are pregnant or intended to and lactating mother.
  • Participants who have heart valve replacement and have known intolerance or allergy to mouth rinses.
  • Participants who have any systemic disease.

研究组 & 干预措施

Kin mouthwash

Placebo Comparator

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

干预措施: Kin (Other)

Co. mouthwash

Active Comparator

15ml twice a day, rinse for 30sec refrain from eating or drinking for 30min

干预措施: Co. (Other)

Distilled water

Placebo Comparator

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

Mean amount plaque between different comparators

时间窗: Time Frame: 4 days

Mean amount plaque between different comparators as anti-plaque agent following 4 days plaque regrowth clinical trial by means of modified quigely hein plaque index \[Turesky, 1970\] and digital plaque image analysis.

次要结局

  • Mean relative changes in Interleukin1 beta levels in gingival crevicular fluid(4 days)
  • Mean bacterial load in saliva(2 hours)
  • Mean relative changes in gingival crevicular fluid flow rate(4 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hayder Raad Abdulbaqi

Principal Investigator

University of Baghdad

研究点 (2)

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