Clinical Investigation to Assess the Efficacy of an Antimicrobial Mouthrinse in the Reduction of Established Plaque and the Improvement of Gum Health: a 6-month Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
研究概览
简要总结
The goal of this clinical trial is to evaluate the clinical efficacy of an antimicrobial mouthrinse, with a particular focus on its effect on established plaque and the improvement of gum health.
Participants will:
- Brush and rinse twice a day with the designated products for 6 months
- Visit the clinic once every 3 months after baseline for reassessment.
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
- •Male and female subjects aged 18-70 years, inclusive.
- •Availability for the 6-month duration of the clinical research study.
- •Good general health based on the opinion of the study investigator.
- •Signed Informed Consent Form.
- •Minimum of 20 natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.5 as determined by the use of the Loe and Silness Gingival Index.
- •Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
排除标准
- •Be under orthodontic treatment.
- •Presence of partial removable dentures.
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •Participants with current moderate or severe periodontitis (periodontitis screening index [PSI] >2 in more than 2 sextants or PSI >3), and/or 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 based on the examiner/PI opinion.
- •An existing medical condition that prohibits eating and/or drinking for periods up to 4 hours.
- •History of alcohol and/or drug abuse.
- •Self-reported pregnancy and/or lactating subjects.
- •Subjects with other oral diseases (including gingival hyperplasia, diseases of the oral mucosa), or any condition that the dental examiner considers exclusionary from the study.
- •Smokers or/and users of tobacco products.
- •Enrolled in an undergraduate, postgraduate, or academic dentistry program
研究组 & 干预措施
Test Group
Subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.
干预措施: Test Mouthrinse (Other)
Control Group
subjects will be instructed to brush their teeth twice daily for two minutes each time with the toothpaste and toothbrush provided. After brushing, subjects will swish with 15 ml of mouthrinse for 30 seconds.
干预措施: Control Mouthrinse (Other)
结局指标
主要结局
Improvement of gum health as measured by the Gingival Index (Löe 1967) between the study groups.
时间窗: 6-month period
Four areas of the tooth (buccal, lingual, mesial, and distal surfaces) will be assessed. Each site is assigned a score from 0 to 3 based on clinical observation: 0 indicates normal gingiva and 3 denotes severe inflammation with marked redness, edema, ulceration, and a tendency toward spontaneous bleeding.
次要结局
- Plaque scores as measured by the Plaque Index (Turesky et al. 1970) between the study groups(6-month period)