NCT05821712已完成3 期
Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Six-month Study in Italy
适应症
干预措施
相关药物
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
- Gingival inflammation
研究概览
简要总结
This 6-month clinical study was designed to investigate clinical efficacy on plaque and gingivitis for the Meridol Base Mouthwash containing 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride as compared to a Negative Control Mouthwash containing 0.057% sodium fluoride after 3 and 6 months of product use.
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
- Triple (Participant, Care Provider, Investigator)
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, ages 18-70, inclusive.
- •Availability for the six-month duration of the clinical research study.
- •Good general health.
- •Initial gingivitis index of at least 1.0 as determined by the use of the Loe-Silness Gingival Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein 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).
- •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
0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash
Experimental
mouthwash
干预措施: 0.2% zinc lactate, 0.17% amine fluoride and 0.0275% sodium fluoride Mouthwash (Drug)
0.057% sodium fluoride Mouthwash
Active Comparator
mouthwash
干预措施: 0.057% sodium fluoride Mouthwash (Drug)
结局指标
主要结局
Gingival inflammation
时间窗: 6 months
Loe-Silness Gingival Index
次要结局
未报告次要终点
研究者
研究点 (1)
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