Six Week Safety and Clinical Efficacy of Experimental Mouth Rinses: Effect on Gingivitis and Plaque
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 157
- 试验地点
- 2
- 主要终点
- Whole-mouth Mean Modified Gingival Index (Mean MGI) After 6 Weeks of Product Use
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of experimental mouth rinse formulations compared to a positive control mouth rinse and a hydroalcohol control mouth rinse for the reduction of gingivitis and plaque when used as an adjunct to tooth brushing during a six-week product usage 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
- Double (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
- •Adequate oral hygiene (That is brush teeth daily and exhibit no signs or oral neglect)
- •A minimum of 20 gradable teeth including 4 molars with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, teeth with veneers, or third molars will not be included in the tooth count
- •A mean gingival index greater than or equal to (>=) 1.95 per the Modified Gingival Index at Baseline (for those in the randomized treatment group)
- •A mean gingival index less than or equals to (<=) 0.75 per the Modified Gingival Index at Baseline (for those in the healthy reference group)
- •A mean plaque index >= 1.95 per the 6 site Turesky modification of the Quigley-Hein Plaque Index at Baseline (for those in randomized treatment groups)
- •Greater than or equal to 10 percent (%) bleeding sites at baseline (for those in randomized treatment groups)
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
- •Dental prophylaxis within four weeks prior to Screening/Baseline 1 visit
- •More than three sites that have periodontal pockets depths measuring 5mm or greater in depth
- •Teeth having periodontal pocket depths measuring more than 3 mm in depth (healthy reference group)
- •History of medical conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures
- •Use of Antibiotics, anti-inflammatory or anticoagulant therapy, phenytoin sodium or diphenylhydantoin, calcium channel blockers, cyclosporin A, immunostimulants/ immunomodulators during the study or within the one month prior to the Baseline 1 exam. Intermittent use of certain anti-inflammatory medication is acceptable at the discretion of the Investigator
结局指标
主要结局
Whole-mouth Mean Modified Gingival Index (Mean MGI) After 6 Weeks of Product Use
时间窗: 6 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).
Whole-mouth Mean Plaque Index (Mean PI) After 6 Weeks of Product Use
时间窗: 6 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).
次要结局
- Whole-mouth Mean Plaque Index (Mean PI) After 4 Weeks of Product Use(4 weeks)
- Percentage of Bleeding Sites, Based on the Expanded Gingival Bleeding Index After 4 and 6 Weeks of Product Use(4 and 6 Weeks)
- Whole-mouth Mean Modified Gingival Index (Mean MGI) After 4 Weeks of Product Use(4 weeks)
- Whole-mouth Mean Expanded Bleeding Index (Mean BI) After 4 and 6 Weeks of Product Use(4 and 6 Weeks)