NCT06048627已完成3 期
Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and Gingivitis: a 6-month Clinical Study
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Whole-mouth Mean Modified Gingival Index (MGI)
研究概览
简要总结
The purpose of this study is to prove whether a fluoride/zinc lactate containing mouthrinse is able to reduce dental plaque and gingival inflammation in patients who have gingivitis when applied twice daily during brushing at home over a period of 12 weeks.
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 (Participant, 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
- •Availability for the six-month duration of the clinical research study.
- •Good general health.
- •Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.5 as determined by the use of the Gingival Index (Löe 1967).
- •Initial plaque index of at least 1.5 as determined by the use of the Plaque Index (Turesky et al. 1970).
- •Signed Informed Consent Form.
排除标准
- •Presence of orthodontic bands.
- •Malign tumor(s) of the soft or hard tissues of the oral cavity.
- •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.
- •Participants who have systemic diseases that require regular systemic medication intake that may affect the gingival condition (e.g. antibiotics, phenytoin, nifedipine, cyclosporine, steroids, antiphlogistics).
- •Participants who require antibiotic treatments for dental appointments.
- •Participants with current moderate or severe chronic or aggressive periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3).
- •Subjects with caries requiring treatment (e.g., caries with cavity) or other oral diseases (including gingival hyperplasia, diseases of the oral mucosa);
- •Smokers or/and users of tobacco products.
- •Persons, who are unable to give their consent (e.g., persons who have limited legal capacity)
研究组 & 干预措施
Mouthwash Test
Active Comparator
干预措施: Amine/zinc lactate/fluoride system (Drug)
Mouthwash Experimental
Experimental
干预措施: negative control (Drug)
结局指标
主要结局
Whole-mouth Mean Modified Gingival Index (MGI)
时间窗: Baseline, 3 weeks, 12 weeks, 24 weeks
Gingivitis, gingival severity and gingival, interproximal scores as measured by the Gingival Index as difference from baseline to 24 weeks between the study groups.
次要结局
- Intraoral scans(Baseline, 3 weeks, 12 weeks, 24 weeks)
- Patient-reported experiences(Baseline, 3 weeks, 12 weeks, 24 weeks)
- Turesky Modification of the Quigley Hein Plaque Index (PI)(Baseline, 3 weeks, 12 weeks, 24 weeks)
研究者
研究点 (1)
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