The Plaque- and Gingivitis Inhibiting Capacity of a Commercially Available Mouthwash Containing Essential Oils and Ethyl Lauroyl Arginate: A Parallel, Split-mouth, Double Blind, Randomized, Placebo-controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 1
- 主要终点
- Plaque index (Silness & Loe 1964)
研究概览
简要总结
A commercially available mouth rinse with ethyl lauroyl arginate and essential oils claims to have enhanced antimicrobial properties as compared to the traditional essential oil products. The aim of the present study was to compare the plaque and gingivitis inhibiting effect of the commercial product containing essential oils with ethyl lauroyl arginate with one placebo and one negative control in a modified experimental gingivitis model. In three groups of healthy volunteers, experimental gingivitis was induced and monitored over 21 days, simultaneously treated with the commercial test solution, 21.6% hydro-alcohol solution and sterile water respectively. The maxillary right quadrant of each individual received mouthwash only, whereas the maxillary left quadrant was subject to both rinsing and mechanical oral hygiene. Compliance and side effects were monitored at day 7, 14, and 21. Plaque and gingivitis scores were obtained at baseline and at day 21.
详细描述
Mouthrinses containing essential oils in 21% - 26% alcohol are claimed to be potent inhibitors of plaque formation, although a recently published study suggests otherwise.
Recently, a new product in this series of mouthwashes was introduced in which an additional antimicrobial agent, Ethyl Lauroyl Arginate, derived from lauric acid and arginine had been added to the standard essential oils and alcohol. Ethyl Lauroyl Arginate acts as a cationic surfactant and has a wide spectrum of activities against Gram positive and - negative bacteria, yeasts and fungi and acts by modifying the permeability of membranes. Ethyl Lauroyl Arginate is used as a multi-functional component in formulations of cosmetic and toiletry products, claiming to act as an anti-static agent and a surfactant with antimicrobial properties. The Scientific Committee on Consumer Safety, has evaluated the safety and use of the ingredient and considered Ethyl Lauroyl Arginate as a safe product when used up to a maximum concentration of 0,15 % in oral dental products. The manufacturer of Essential Oils with Ethyl Lauroyl Arginate claims that Ethyl Lauroyl Arginate prevents the formation of biofilms, and represents a totally new way to combat biofilm-diseases like caries, gingivitis and periodontitis. Moreover, the manufacturer announces that the product reduces plaque colonization of dental surfaces with up to 42.6% and bleeding with up to 50.9% in 4 weeks.
Few or no clinical studies of this new mouthwash have been published, although some informational material is cited in marketing pamphlets.
Thus, the Aim of the present study was to test the clinical plaque- and gingivitis inhibiting capacity of Essential Oils with Ethyl Lauroyl Arginate, with or without mechanical oral hygiene, using a modified experimental gingivitis model, with 21.6 % hydroalcoholic and sterile water as controls.
The HYPOTHESIS was that the test solution was equally effective in preventing dental plaque as the placebo solution in the Experimental gingivitis model.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy subjects from both gender snon-smoking aged 20-55yr having at least three of the following teeth in maxillary right and left quadrant: the canine, 1st bicuspid, 2nd bicuspid, 1st molar, healthy gingiva and periodontium.
排除标准
- •pregnancy lactation any chronic diseases clinical signs or symptoms of acute infection in the oral cavity any prescribed or non-prescription systemic or topical medication except oral contraceptives clinical parameters judged as unacceptable by the principle investigator use of systemic antibiotics the last 3 months prior to the start of the study history of alcohol or drug abuse participation in other clinical studies in the last 4weeks
研究组 & 干预措施
21.6% hydroalcoholic
a hydro-alcohol solution made from 96% ethanol diluted with sterilized water to the final concentration of 21.6%.
Intervention: Rinsing 30 sec with placebo comparator twice daily for 21 days
干预措施: Placebo (Other)
Plain sterile water
Plain sterile water.
Intervention: Rinsing 30 sec with sham comparator twice daily for 21 days
干预措施: Water (Other)
结局指标
主要结局
Plaque index (Silness & Loe 1964)
时间窗: 21 days
0= No plaque 1. A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may be seen in situ only after application of disclosing solution or by using the probe on the tooth surface. 2. Moderate accumulation of soft deposit s within the gingival pocket, or the tooth and gingival margin which can be seen with the naked eye. 3. Abundance of soft matter within the gingival pocket and/or on the tooth and gingival margin.
次要结局
- The gingival index (GI) (Løe & Silness 1963)(21 days)
研究者
Hans Ragnar Preus
Professor
University of Oslo