A Clinical Study to Investigate a New Mouthwash Containing 0.075% CPC, and 0.1% Hyaluronic Acid and 0.28% Zinc Lactate as Compared to a Fluoride Mouthwash Containing 0.044% NaF in Reducing Plaque and Helping Prevent Gum Problems on Dental Implants Over a 6-month Period of Product Use
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Mombelli Modified Gingival Index
研究概览
简要总结
The objective of this six-month clinical research study is to evaluate the clinical efficacy of a new mouthwash on helping prevent gum problems (gingival index scores ) in adults as compared to a control mouthwash.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Availability for the six-month duration of the clinical research study.
- •Good general health.
- •Minimum of two dental implants (2 different quadrants ), each implant must have a restoration.
- •Initial mucositis index of at least 1 .0 as determined by the use of the Mombelli Modified Gingival Index.
- •Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque Index.
- •Signed Informed Consent Form.
排除标准
- •Presence of orthodontic bands.
- •Tumor (s ) of the soft or hard tissues of the oral cavity.
- •Advanced periodontal disease (purulent exudate, tooth mobility, and /or extensive loss of periodontal attachment or alveolar bone ) or peri-implantitis.
- •Five or more carious lesions requiring immediate restorative treatment.
- •Antibiotic use any time during the one-month period prior to entry into the study.
- •Participation in any other clinical study or test panel within the one month prior to entry into the study.
- •Dental prophylaxis during the past two weeks prior to baseline examinations.
- •History of allergies to oral care /personal care consumer products or their ingredients.
- •On any prescription medicines that might interfere with the study outcome.
- •An existing medical condition that prohibits eating or drinking for periods up to 4 hours.
- •History of alcohol or drug abuse.
- •Self-reported pregnant or lactating subjects
研究组 & 干预措施
New Mouthwash containing CPC, Zinc and Hyaluronic acid
After brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening ) for 30 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months
干预措施: Cetylpyridinium Chloride, Zinc Lactate and Hyaluronic Acid Mouthwash (Drug)
Fluoride Mouthwash
After brushing in the morning, 10 ml of mouthwash shall be used for each rinsing, 1 time daily (morning ) for 60 seconds each time. No further rinsing with water shall be occurred after spilt out and after each mouthwash rising. Each qualified subject will follow this specific application for 6 months.
干预措施: PhosFlur Mouthwash (Drug)
结局指标
主要结局
Mombelli Modified Gingival Index
时间窗: six month
Initial mucositis index of at least 1.0 as determined by the use of the Mombelli Modified Gingival
Mombelli Modified Plaque Index
时间窗: six month
Initial plaque index of at least 1 .5 as determined by the use of the Mombelli Modified Plaque
次要结局
未报告次要终点