Dental Plaque Prevention Efficacy Evaluation and Comparison of a Stannous Fluoride Toothpaste
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index)
研究概览
简要总结
This randomized, stratified, double-blind, two-cell parallel clinical study evaluated the dental plaque prevention efficacy of a stannous fluoride toothpaste compared to a sodium fluoride control toothpaste following a professional dental prophylaxis. Adult subjects brushed twice daily for 14 days with their assigned dentifrice. Plaque was assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index at baseline, Day 1, and Day 14 following periods of oral hygiene abstention.
详细描述
This two-week, randomized, double-blind, parallel-group study evaluated plaque prevention following dental cleaning. Subjects meeting plaque qualification criteria underwent a complete prophylaxis and were randomized to either a stannous fluoride test dentifrice or a sodium fluoride control dentifrice. Subjects brushed twice daily for two minutes with the assigned product. Plaque accumulation was assessed at baseline, after one day of use, and after 14 days of use following overnight abstention from oral hygiene. Plaque was disclosed and scored on facial and lingual tooth surfaces using the Lobene-Soparkar modified Turesky Plaque Index. Treatment comparisons were performed using ANCOVA with baseline plaque as a covariate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health based on medical history
- •Minimum of 18 natural teeth with scorable surfaces
- •Baseline mean plaque score ≥2.0
- •Willing to refrain from non-study oral hygiene products
- •Willing to abstain from oral hygiene prior to study visits
- •Able and willing to comply with study procedures
排除标准
- •Known allergy to oral care products
- •Conditions limiting normal brushing
- •Significant medical conditions affecting study participation
- •Pregnant or nursing females
- •Severe periodontal disease
- •Recent dental prophylaxis
- •Recent participation in another dental study
研究组 & 干预措施
Sodium Fluoride Control Dentifrice
Dentifrice containing sodium fluoride, serving as the control comparator.
干预措施: Sodium Fluoride Dentifrice (Drug)
Stannous Fluoride Toothpaste
Dentifrice containing stannous fluoride evaluated for plaque prevention compared to sodium fluoride control.
干预措施: Stannous Fluoride Toothpaste (SnF) (Drug)
结局指标
主要结局
Whole-Mouth Dental Plaque Score (Turesky Modified Quigley-Hein Index)
时间窗: Day 14 (12 hours post-brushing following 14 days of twice-daily use)
Mean whole-mouth plaque index score assessed using the Lobene-Soparkar modification of the Turesky Modification of the Quigley-Hein Plaque Index. Treatment comparisons performed using ANCOVA with baseline plaque score as a covariate.
次要结局
- Whole-Mouth Dental Plaque Score at Day 1(Day 1 (12 hours post-brushing))