Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Three Month Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Gingivitis Scores
研究概览
简要总结
The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.
详细描述
This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.
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)
盲法说明
CRO-2019-03-PG-SNF-FL-BGS Product XXX Brush your teeth twice daily (morning and evening) for two (2) minutes each time.
Cover the length of the toothbrush bristles with the toothpaste. For investigational use only by the study participant. Not for sale. For Adult Use Only. Keep out of reach of children under 6 years.
In case of emergency or for further information contact:
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
- •Subjects, ages 18-70, inclusive.
- •Availability for the six-month duration ofthe clinical research 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 partial denture.
- •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.
- •Antibiotic use 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.
- •Dental prophylaxis during 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.
- •Pregnant or lactating subjects.
研究组 & 干预措施
Fluoride Control
Colgate Cavity Protection 0.76% as Na MFP Toothpaste
干预措施: Colgate Cavity Protection toothpaste (Drug)
Colgate Total SF
Colgate Total Clean Mint White Paste 1100 ppm F Toothpaste
干预措施: Colgate Total SF (Drug)
结局指标
主要结局
Gingivitis Scores
时间窗: 3 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 Score
时间窗: 3 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