Twelve Week Clinical Efficacy of Virtually Supervised Mouth Rinse and Flossing: Effect on Plaque and Gingivitis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 209
- 试验地点
- 2
- 主要终点
- Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of brushing, flossing, and rinsing with an alcohol containing essential oil mouth rinse; brushing and flossing; versus brushing and rinsing with an alcohol containing essential oil mouth rinse; and brushing only for the prevention and reduction of plaque and gingivitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Able to read and understand (participants capable of reading the documents)
- •Adequate oral hygiene (that is brush teeth daily and exhibit no signs of oral neglect)
- •Negative pregnancy urine tests (females of childbearing potential only)
- •Females of childbearing potential must be using a medically-acceptable method of birth control for at least one month prior to Visit 1 and agree to continue using this method during their participation in the study
- •A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count
- •A minimum of 10 percent (%) bleeding sites based on the expanded bleeding index (BI)
- •Participants will have evidence of some gingivitis; there will be no minimum or maximum mean MGI score for gingivitis or TPI score for plaque; mild to severe gingivitis and mild to moderate periodontitis
- •No more than 3 sites having pocket depths of 5 millimeter (mm) and no sites that are greater than 5 mm in depth
排除标准
- •History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes, mouth rinses and red food dye; Known allergy or sensitivity or history of significant adverse effects to any of the investigational product and/or product ingredients (or other ingredients in the products)
- •Dental prophylaxis within four weeks prior to Screening/Baseline visit
- •History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •Use of antibiotics, anti-inflammatory or anticoagulant therapy during the study or within the one month prior to the Baseline exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the investigator
- •Suspected alcohol or substance abuse (example., amphetamines, benzodiazepines, cocaine, marijuana, opiates
结局指标
主要结局
Mean Turesky Plaque Index (TPI) Score After 12 Weeks of Product use
时间窗: 12 Weeks
Plaque area will be scored by the Turesky modification of the Quigley-Hein Plaque Index, on 6 surfaces (distobuccal, midbuccal and mesiobuccal, distolingual, midlingual and mesiolingual) of all scorable teeth, following disclosing: 0 (No Plaque); 1 (Separate flecks or discontinuous band of plaque around the gingival (cervical) margin); 2 (Thin (up to 1 millimeter \[mm\]), continuous band of plaque at the gingival margin); 3 (Band of plaque wider than 1mm but less than1/3 of the surface); 4 (Plaque covering 1/3 or more, but less than 2/3 of the surface); 5 (Plaque covering 2/3 or more of the surface).
Whole-mouth Mean Modified Gingival Index (MGI) Score After 12 Weeks of Product use
时间窗: 12 Weeks
Gingivitis will be assessed by the Modified Gingival Index on the buccal and lingual marginal gingivae and interdental papillae of all scorable teeth: 0 (Normal \[absence of inflammation\]), 1 (Mild inflammation \[slight change in color, little change in texture\] of any portion of the entire gingival unit); 2 (Mild inflammation of the entire gingival unit); 3 (Moderate inflammation \[moderate glazing, redness, edema, and/or hypertrophy\] of the gingival unit); 4 (Severe inflammation \[marked redness and edema/hypertrophy, spontaneous bleeding, or ulceration\] of the gingival unit).
次要结局
- Whole-mouth Mean Turesky Plaque Index (TPI) Score After 4 Weeks of Product use(4 Weeks)
- Whole-mouth Mean Modified Gingival Index (MGI) Score After 4 Weeks of Product use(4 Weeks)
- Whole-mouth and Interproximal Mean Bleeding Index (BI) After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Marginal Mean Expanded Bleeding Index (EBI) Score After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Interproximal of the Proximal Marginal Plaque Index Score After 4 and 12 Weeks(4 Weeks and 12 Weeks)
- Marginal and Interproximal Mean Modified Gingival Index (MGI) Score After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Whole-mouth and Interproximal Percent Bleeding Sites, Based on the EBI Score After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)
- Marginal and Interproximal Mean Turesky Plaque Index (TPI) Score After 4 and 12 Weeks of Product use(4 Weeks and 12 Weeks)