NCT07223060已完成2 期
A Randomized, Single-center, Two-cell, Double-blind and Parallel-group Design Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a Test Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% Sodium Monofluorophosphate in Controlling Supragingival Calculus Formation Over a 12-week Period.
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Supragingival calculus formation via Volpe-Manhold Calculus Index
研究概览
简要总结
To evaluate the comparative clinical efficacy of a test toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate in controlling supragingival calculus formation over a 12-week period.
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
- Quadruple (Participant, Care Provider, 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
- •Subjects were required to sign an Informed Consent form
- •Subjects had to be in general good health
- •Male and female adults between the ages of 18-70 (inclusive)
- •Six (6) scoreable mandibular anterior teeth free of large restorations or dental prosthetic crowns
- •Subjects were required to possess a Volpe-Manhold Calculus Index of at least 7.0
- •Subjects had to be able to participate for the full duration (20 weeks) of the study
排除标准
- •Presence of orthodontic appliances or removable prosthesis at the lower jaw or more than one mandibular anterior tooth with a prosthetic crown or veneer
- •Tumor(s) or significant pathology of the soft or hard tissues of the oral cavity
- •Moderate or advanced periodontal disease
- •Five or more carious lesions requiring immediate care
- •Use of antibiotics or steroids any time during one month prior to entry into the study
- •Participation in any other clinical study or panel test
- •Pregnant or breast feeding women
- •History of allergies to dentifrice and personal care ingredients
- •Allergies to dentifrice products
- •Medical reasons that prohibit eating or drinking for 4 hours prior to clinical facility visit.
研究组 & 干预措施
Test 1 toothpaste
Experimental
干预措施: 0.454% stannous fluoride (Drug)
Test 2 toothpaste
Active Comparator
干预措施: 0.76% sodium monofluorophosphate (Drug)
结局指标
主要结局
Supragingival calculus formation via Volpe-Manhold Calculus Index
时间窗: baseline and 12 week measurement
index for comparing the amount of dental calculus
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
3 期
A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New ToothpasteNCT07223073Colgate Palmolive80
已完成
不适用
A Study to Evaluate the Effect of a Stannous Fluoride Toothpaste on the Oral MicrobiomeOral HealthNCT06048809HALEON56
撤回
不适用
Clinical Efficacy of Fluoride Toothpastes Using an In Situ Caries ModelDental CariesNCT02436473GlaxoSmithKline
进行中（未招募）
4 期
Assessing Gingivitis and Plaque From a Marketed ToothpasteGingivitisNCT07158112Procter and Gamble120
已完成
4 期
A Clinical Study Investigating the Efficacy of a Stannous Fluoride Dentifrice in Improving Gingival Health After Twice Daily Use for 3 WeeksGingivitisNCT04050722GlaxoSmithKline130