Clinical Efficacy in Reducing Established Dental Plaque and Gingivitis of a Toothpaste Containing 0.3% Triclosan, 2% Copolymer / Sodium Fluoride and a Manual Toothbrush as Compared to an Oral Hygiene Multi-component Regimen Encompassing the Use of a Manual Toothbrush, a Toothpaste Containing Stannous Fluoride / Sodium Hexametaphosphate and a Mouthwash Containing 0.07% Cetylpyridinium Chloride
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 179
- 试验地点
- 1
- 主要终点
- Gingivitis Scores
研究概览
简要总结
The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Male and female subjects, ages 18-70, inclusive.
- •Availability for the six-month duration of the study.
- •Good general health.
- •Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
- •Signed Informed Consent Form.
排除标准
- •Presence of orthodontic bands.
- •Presence of partial removable dentures.
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- •Five or more carious lesions requiring immediate restorative treatment.
- •Use of antibiotics any time during the one month prior to entry into the study.
- •Participation in any other clinical study or test panel within the one month prior to entry into the study.
- •Pregnant women or women who are breast feeding.
- •Dental prophylaxis received in the past two weeks prior to baseline examinations.
- •History of allergies to oral care/personal care consumer products or their ingredients.
- •On any prescription medicines that might interfere with the study outcome.
- •An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
- •History of alcohol or drug abuse
研究组 & 干预措施
Toothpaste
Triclosan/fluoride toothpaste
干预措施: Triclosan/fluoride toothpaste (Drug)
Toothpaste + mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
干预措施: stannous fluoride toothpaste (Drug)
Toothpaste + mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
干预措施: Cetylpyridinium chloride mouthwash (Drug)
Fluoride only Toothpaste + mouthwash
Fluoride only toothpaste + Fluoride only Mouthwash
干预措施: fluoride only toothpaste (Drug)
Fluoride only Toothpaste + mouthwash
Fluoride only toothpaste + Fluoride only Mouthwash
干预措施: Fluoride only mouthwash (Drug)
结局指标
主要结局
Gingivitis Scores
时间窗: 6 months
Gingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Dental Plaque Scores
时间窗: 6 months
Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
次要结局
未报告次要终点