Antibacterial Effect of Paradontax Toothpaste
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Plaque Index (PI)
研究概览
简要总结
The purpose of the study is to test the antibacterial effect of Parodontax toothpaste on plaque formation, and thus gingivitis compared to placebo toothpaste.
Each subject will be given 2 plastic splints that are individually adapted to their quadrant 1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses daily. Each person's set of teeth is otherwise professionally cleaned.
详细描述
Each subject will be given 2 plastic splints that are individually adapted to their quadrant 1 and 2. In the splint in the 1st quadrant, Parodontax test toothpaste will be placed, while in the splint in the 2nd quadrant, regular toothpaste will be placed, which the subject uses daily. Each person's teeth is otherwise professionally cleaned.
Home procedure: The subject first rinses the mouth with water for 30 sec. Then both splints are placed on the teeth in the 1st quadrant and 2nd quadrant, respectively, and the rest (lower jaw) is brushed with the subject's regular toothpaste. The brace should be on for 1 min while cleaning the teeth in the lower jaw as usual, with its usual commercial toothpaste. After 1 minute, rinse your mouth with water for 30 seconds. Then the splints are removed and the mouth is immediately rinsed with water for another 30 sec. The procedure is repeated twice a day (morning and evening) for 3 weeks (21 days). In this way, the test person becomes his own control (1st quadrant versus 2nd quadrant), and the individual plaque quality is subordinate to what it would not otherwise be in a 2-group study. Furthermore, individual brushing technique will not be an issue, as we only test the antibacterial effect of the toothpaste in the splint quadrants. It is the antibacterial effect of Parodontax we test, not affected by brushing technique.
Health information that includes age, medication use, allergies, diseases, and tobacco use. Following the test period, registration of plaque (Silness&Loe/Quigley&Hines) and gingival bleeding (Loe&Silness) will be registered
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy people of both sexes
- •age 18-35 years
- •Have at least three of the following teeth: 16, 15, 14, 13, 23, 24, 25, 26 with healthy gingiva.
- •Non-smokers
- •Has signed an informed consent document
排除标准
- •Pregnancy and breast-feeding.
- •Any chronic disease Clinical or other symptoms of oral disease
- •Any prescribed or over-the-counter systemic or topical medication with the exception of oral contraceptives used within one week prior to the start of the study.
- •Haematological and clinical / chemical parameters considered unacceptable by the project manager.
- •Use of antibiotics within the last three months before the start of the study.
- •Alcohol or drug / drug abuse
- •Participation in other clinical studies in the last 4 weeks before the start of the study.
结局指标
主要结局
Plaque Index (PI)
时间窗: 21 days
Amount of plaque at surfaces
次要结局
- Gingival bleeding (GI)(21 days)
- Presence of plaque at entire tooth(21 days)
研究者
Odd Carsten Koldsland
Associate professor
University of Oslo