A Clinical Study to Evaluate Anti-Plaque Benefit of a Gel in a Modified- 4 Day Plaque Model
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Mean Turesky Modified Quigley-Hein Index at Day 4
研究概览
简要总结
The objective of the study is to evaluate anti-plaque efficacy of a preventive treatment gel in a modified 4-day plaque model.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Single (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
- •Provide written informed consent prior to participation and be given a signed copy of the informed consent form;
- •Be 18 years of age or older;
- •Agree not to participate in any other oral/dental product studies during the study;
- •Agree to delay any elective dentistry (including dental prophylaxis) until the study has been completed;
- •Agree to refrain from the use of any non-study oral hygiene products (subjects who are regular flossers will be allowed to floss during acclimation and wash-out periods);
- •Agree to use an oral hygiene product that contains stannous fluoride;
- •Agree to refrain from any form of non-specified oral hygiene during the treatment period, including the use of products such as floss, toothpicks for plaque removal, and chewing gum;
- •Agree to refrain from any oral hygiene, eating and drinking after 11:00 PM the evening before plaque measurements on Day 0 and Day 4 of the treatment periods;
- •Agree to return for all scheduled visits and follow study procedures;
- •Possess a minimum of 20 natural teeth with scorable facial and lingual surfaces, of which at least 4 are molars; and,
- •Be in good general health, as determined by the Investigator/designee based on a review of the health history/update for participation in the study.
排除标准
- •Have a medical condition requiring pre-medication prior to dental procedures;
- •Have taken antibiotics within 2 weeks of the acclimation period or anticipate taking antibiotics at any time during the study;
- •Have a history of allergies or hypersensitivity to dyes or dentifrices that contain stannous fluoride;
- •Have removable or orthodontic appliances which interfere with obtaining 20 gradable teeth;
- •Have previously demonstrated an inability to comply with study visit requirements;
- •Have rampant caries, open or untreated caries, severe gingivitis or advanced periodontitis requiring prompt treatment; or,
- •Present with any disease or condition(s) that could be expected to interfere with examination procedures or the subject's safe completion of the study.
研究组 & 干预措施
Preventive Gel
0.4% stannous fluoride
干预措施: Preventive Gel (Drug)
Marketed Control
0.243 % Sodium Fluoride
干预措施: Marketed Control (Drug)
结局指标
主要结局
Mean Turesky Modified Quigley-Hein Index at Day 4
时间窗: Day 4
The Turesky Modified Quigley-Hein Index was scored on six surfaces (distobuccal, midbuccal, mesiobuccal, distolingual, midlingual and mesiolingual) to assess plaque on all gradable teeth. Whole mouth average plaque scores were calculated for each subject and tooth surfaces by totaling the scores and dividing by the number of gradable sites examined. the scoring criteria is below; (0) No Plaque; (1) Separate flecks of plaque at the cervical margin; (2) A thin, continuous band of plaque (up to 1 mm) at the cervical margin; (3) A band of plaque wider than 1 mm, but covering less than one third of the side of the crown of the tooth; (4) Plaque covering at least one third, but less than two thirds of the side of the crown of the tooth; (5) Plaque covering two thirds or more of the side of the crown of the tooth.
次要结局
- Digital Plaque Imaging(Day 4)
- Overall Baseline Mean Digital Plaque Imaging(Baseline)
- Mean Turesky Modified Quigley-Hein Index at Baseline(Baseline)