An Investigation of the Effects of a Oral Hygiene Regimen in Irregular Flossers on Gingivitis and Plaque
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
研究概览
简要总结
In the current study, Sonicare AirFloss (AF) will be used in combination with a Manual Toothbrush (MTB) in a population of manual toothbrush users who are irregular flossers and who exhibit signs of moderate gingivitis. The alternate test arm will be allocated to a No Intervention group and will be given no test products or instruction other than to change none of their typical at home oral hygiene habits.
The aim of this study is to investigate how an AF and MTB oral hygiene intervention will affect a population of irregular flossers using the residual protein concentration method as an interproximal plaque efficacy assessment. Gingivitis reduction will be assessed using the Modified Gingival Index (MGI) and Gingival Bleeding Index (GBI) indices
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •4.1 Inclusion Criteria
- •Subjects accepted into the study must meet the following requirements:
- •are 18-70 years;
- •are in generally good health;
- •have a minimum of 20 natural teeth (excluding 3rd molars);
- •have 1 qualifying test site in each posterior quadrant;
- •are a regular manual toothbrush user (prior periodic use of powered toothbrushes in other studies permitted);
- •Irregular Flossers defined as using dental floss ≤ 2 days a week;
- •be willing and able to comply with study procedures and be available at all times required for participation;
- •have a Gingival Bleeding Index > 1 on at least 20 sites;
- •be a non-smoker.
排除标准
- •Subjects will be excluded from the study if they;
- •have systemic diseases such as Down's syndrome, or known AIDS/HIV;
- •have insulin dependent Diabetes;
- •are pregnant or nursing by subject report;
- •have a cardiac pacemaker or AICD;
- •are undergoing or require extensive dental or orthodontic treatment;
- •require antibiotic treatment for dental appointments;
- •have used antibiotics within 4 weeks of enrollment;
- •are currently using prescription-dose anti-inflammatory medications or anticoagulants (including aspirin);
- •have heavy deposits of calculus, either supragingival and/or subgingival;
- •have severe gingivitis or periodontitis;
- •have extensive crown or bridge work and/or rampant decay;
- •are currently use bleaching trays;
- •have any oral or extraoral piercing on lips or in mouth with ornament or accessory;
- •have a professional prophylaxis within 4 weeks of study;
- •have participated in a prior study ≤ 20 days;
- •are employed by an oral healthcare products company or dental research institution.
研究组 & 干预措施
Airflosser
Use of Airflosser
干预措施: Airflosser (Device)
Manual Floss
Normal Routine
干预措施: Manual Floss (Device)
结局指标
主要结局
The Effect of Sonicare AirFloss + MTB Treatment Versus the Control Group
时间窗: Four Months
The primary objective of the study is to compare the effect of Sonicare AirFloss + MTB treatment versus the Control Group on gingival inflammation (as measure by number of bleeding sites, and reduction in MGI) after four weeks of use.
次要结局
- Plaque(4 Weeks)
- Percentage of Bleeding Sites(2 Weeks)
- Number of Participants With Adverse Events as a Measure of Safety and Tolerability(4 Months)
- Gingival Inflammation(4 weeks)
- Number of Bleeding Sites(2 Weeks)