A Randomized Crossover Clinical Evaluation of a Stannous Fluoride Containing Dentifrice on Oral Malodor
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in Odor Intensity Score (OI
研究概览
简要总结
This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Adult subjects brushed twice daily with each product during separate treatment periods following standardized wash-out periods. Oral malodor was assessed using trained organoleptic judges applying a validated Odor Intensity (OI) scale at baseline and multiple post-treatment time points.
详细描述
This four-week, randomized, double-blind crossover study enrolled generally healthy adult subjects with qualifying intrinsic oral malodor. Following screening and an acclimation wash-out period using an ADA-accepted sodium fluoride dentifrice, subjects were randomized to one of two treatment sequences: TheraBreath® Healthy Gums Toothpaste or Crest® Cavity Protection Toothpaste. Each treatment period included supervised and at-home twice-daily brushing without tongue brushing or use of non-study oral hygiene products. Oral malodor was evaluated at baseline, 12-hour overnight, and 4- and 8-hour post-brushing time points on Day 1 and Day 7 using standardized organoleptic assessments performed by three trained judges. Safety was monitored through oral examinations and subject interviews. Treatment comparisons were analyzed using ANCOVA models appropriate for crossover designs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults ≥18 years of age in good general health
- •Baseline odor intensity score ≥2 after approximately 12 hours of oral hygiene abstention
- •Intra-oral source of oral malodor
- •At least 18 natural teeth
- •Willing to comply with oral hygiene, dietary, and behavioral restrictions
- •Able to provide informed consent
排除标准
- •Allergy to oral hygiene products
- •Pregnant or nursing
- •Serious medical conditions affecting oral malodor
- •Recent antibiotic or anti-inflammatory medication use
- •Smoker or user of smokeless tobacco
- •Advanced periodontal disease, frank caries, or significant oral pathology
- •Participation in another oral care study within 30 days
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 malodor reduction compared to sodium fluoride control.
干预措施: Stannous Fluoride Toothpaste (SnF) (Drug)
结局指标
主要结局
Change in Odor Intensity Score (OI
时间窗: Baseline to 12-hour overnight assessment after 7 days of product use
次要结局
- Change in Odor Intensity Score at Day 1(Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment.)