Antiplaque Effect of Essential Oils and 0.2% Chlorhexidine on an in Situ Model of Oral Biofilm Growth: a Randomised Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Bacterial vitality (%)
研究概览
简要总结
The accumulation and maturation of oral biofilm in the gingival margin is widely recognised to be the primary aetiological factor in the development of chronic gingivitis. Based on this association, the current treatment of gingivitis is focused on biofilm disruption, which will normally include mechanical processes, both professionally and at home. However, for patients, it is not easy to achieve a proper level of plaque control. The efficient plaque control techniques are very time consuming and require a special motivation and skills for their optimum use. It was at this point where mouthwashes become important, due to the fact that they include diverse types of antimicrobial agents to complement the results of mechanical oral hygiene measures.
Chlorhexidine is considered the "gold standard" of oral antiseptics; nevertheless it has not been recommended for long periods of time due to its well-known secondary effects. All of these inconveniences have limited its acceptability among dental professionals and users; in contrast, however, are the exceptional antiseptic properties, promoting the interest of researchers in other alternative antiplaque agents. Mouthwashes containing essential oils in their formulation have received a lot of attention. Their antiplaque activity has been demonstrated in numerous clinical studies, in which they were used in conjunction with mechanical oral hygiene measures.
In order to achieve a better understanding of the clinical effects that antimicrobial agents produce in the interior of the biofilm, it is necessary to apply a methodology in which the biofilm grows directly in the interior of the oral cavity but its three dimensional structure is not distorted by manipulation.
The aim of this study was to evaluate the in situ antiplaque effect of 2 antimicrobial agents (essential oils formulation and 0.2% chlorhexidine) in the short term with a posterior analysis on "non-destructured" biofilm with Confocal Laser Scanning Microscope combined with fluorescence staining.
详细描述
The volunteers wore two individualised splint which was capable of holding 6 glass disks (6 mm in diameter, 1 mm thickness); this was polished at 800 grit. . These splints are formed of 2 sheets, an internal 1 mm soft vinyl sheet where the disks are attached and an external 1 mm rigid one made of polyethylene terephtalate that is fenestrated.
• Mouthwash protocol During the 96 hour (4 days) duration of each course of study, each volunteer wore the splints with the glass disks, withdrawing them from the oral cavity only during meals (they were stored in an opaque container in humid conditions) and to perform oral hygiene procedures, using only the mechanical removal of bacterial plaque with water, without the use of any toothpaste or mouthwash.
Using the permitted mechanical oral hygiene measures (without the splints), the volunteers performed the following protocols based on the manufacturers' instructions, with the splints in the oral cavity, during the 4 days in the morning (8.30) after breakfast and at night (22.00) after dinner:
A) 20 ml rinses for 30 seconds with essential oils/2 times daily. ----14 days---- B) 10 mL rinses for 30 seconds with 0.2% chlorhexidine/2 times daily. ----14 days---- C) 20 mL rinses for 30 seconds with sterile water (negative control). Using an internet-based balanced randomisation system, indicating the mouthwash that each subject would use first, second and third, all volunteers performed the 3 rinsing cycles, with a rest period of 14 days between each test.
• Collection of the samples of Plaque like-biofilm Sample collection was done individually at 8 am in the morning, so that the samples of each volunteer were analysed on different days. It was determined that a minimum of 10 hours should have elapsed since the last mouthwash on the previous night.
研究设计
- 研究类型
- Interventional
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Systemically healthy adults.
- •Minimum of 24 permanent teeth.
- •No gingivitis (Community Periodontal Index score = 0).
- •No periodontitis (Community Periodontal Index score = 0).
- •Absence of untreated caries.
排除标准
- •Smoker or former smoker.
- •Presence of dental prostheses.
- •Presence of orthodontic devices.
- •Antibiotic treatment or routine use of oral antiseptics in the previous 3 months.
- •Presence of any systemic disease that could alter the production or composition of saliva.
研究组 & 干预措施
Essential oils/0.2% chlorhexidine/Sterile water
A) 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1). -----14 days----- B) 10 mL rinses for 30 seconds with 0.2% chlorhexidine/2 times daily (1/0/1). -----14 days----- C) 20 mL rinses for 30 seconds with sterile water (1/0/1).
干预措施: Essential oils (Drug)
Essential oils/0.2% chlorhexidine/Sterile water
A) 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1). -----14 days----- B) 10 mL rinses for 30 seconds with 0.2% chlorhexidine/2 times daily (1/0/1). -----14 days----- C) 20 mL rinses for 30 seconds with sterile water (1/0/1).
干预措施: 0.2% chlorhexidine (Drug)
Essential oils/0.2% chlorhexidine/Sterile water
A) 20 ml rinses for 30 seconds with essential oils/2 times daily (1/0/1). -----14 days----- B) 10 mL rinses for 30 seconds with 0.2% chlorhexidine/2 times daily (1/0/1). -----14 days----- C) 20 mL rinses for 30 seconds with sterile water (1/0/1).
干预措施: Sterile water (Drug)
结局指标
主要结局
Bacterial vitality (%)
时间窗: 10 hours after the last mouthwash
ratio of alive/dead bacteria.
Biofilm thickness (microns)
时间窗: 10 hours after the last mouthwash
thickness of the biofilm from the base of the substrate to the top surface of the biofilm
covering grade (%)
时间窗: 10 hours after the last mouthwash
area of the substrate that is covered by the biofilm after the 4 days of treatment
次要结局
未报告次要终点
研究者
Inmaculada Tomas
Senior Lecturer
University of Santiago de Compostela