Effect of an Amine Fluoride/Stannous Fluoride Containing Mouthrinse on Gingival Inflammation,Plaque Development, Discoloration and Bacterial Plaque Composition Over Six Months.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Reduction in gingivitis
研究概览
简要总结
The purpose of this study is to determine whether rinsing with an amine fluoride/stannous flouride mouthrinse in addition to daily tooth brushing is more effective than tooth brushing alone.
详细描述
Gingivitis prevalence is 100% among the population. This is mostly due to an inadequate mechanical cleaning of the teeth. However, remaining dental biofilm can be approached by antibacterial mouthrinses. As a consequence of regular use of these mouthrinses, gingivitis can be reduced. Amine fluoride/stannous flouride mouthrinse (ASF)has proved its efficacy in several studies. In the previous years, a new formulation that does not contain ethanol anymore was introduced in the market. Therefore, it is the aim of the study to proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone. In addition, effects on dental plaque, discoloration of teeth and bacterial colonization should be studied.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy male and female adults aged ≥18 years.
- •Participants who have gingivitis/mild chronic periodontitis (approximal probing depth ≤ 3.5 mm at ≥ 80 % of the sites and at ≤ 20 % of the sites > 3.5 mm and < 5 mm).
- •Participants must have read, understood and signed the informed consent form.
- •Participants who have a GI ≥ 1.3 at baseline.
- •Participants who have at least 20 own teeth excluding the wisdom teeth (incl. 16 natural crowns).
- •Participants who have an acceptable compliance according to the investigators' assessment.
排除标准
- •Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e. g. phenytoin, nifedipine, cyclosporine, antibiotics, steroids, antiphlogistics).
- •Participants who require antibiotic treatments for dental appointments (endocarditis prophylaxis).
- •Participants who were treated with antibiotics 8 weeks before recruitment and during the course of the study.
- •Participants who were treated with any antibacterial mouthrinse 6 weeks before recruitment.
- •Participants who use other than the recommended mouthrinse or toothpaste during the study period.
- •Participants who have moderate and severe chronic or aggressive periodontitis.
- •Participants who have irregularities of the gingival tissues, e. g. hyperplastic gingiva, mucosal diseases.
- •Participants who have rampant caries.
- •Participants under guardianship or without freedom by administrative or legal award.
- •Known hypersensitivity or allergy to the study product and standard toothpaste ingredients used in the present study.
- •Known pregnancy or breast feeding during the course of the study.
- •Participation in another clinical trial or receipt of an investigational compound/treatment at the same time and 4 weeks prior to inclusion.
研究组 & 干预措施
amine fluoride/stannous fluoride
Amine fluoride/stannous fluoride mouthrinse in addition to mechanical oral hygiene
干预措施: amine fluoride/stannous fluoride (Drug)
结局指标
主要结局
Reduction in gingivitis
时间窗: 6 months
To proof whether rinsing with ASF adjunctive to mechanical oral hygiene is more effective on gingivitis reduction than mechanical oral hygiene alone.
次要结局
- Bacterial colonization(6 months)
- Adverse events(6 months)
- Discoloration of teeth(6 months)
- Reduction in plaque(6 months)