Study to Assess the Efficacy of Two Brushing Regimens in the Reduction of Dental Plaque and Aid of Gum Problems
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
- Quigley and Hein Plaque Index
研究概览
简要总结
The objective of this twelve-week clinical research study is to assess the efficacy of two brushing regimens: 1) toothpaste with mouthwash containing sodium fluoride/zinc and manual toothbrush as compared to 2) regular fluoride toothpaste and manual toothbrush in the reduction of dental plaque and aid of gum problems.
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
- 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
- •Signed Informed Consent Form.
- •Male and female subjects aged 18-70 years, inclusive.
- •Availability for the twelve-week duration of the clinical research study.
- •Good general health based on the opinion of the study investigator
- •Minimum of 20 permanent natural teeth (excluding third molars).
- •Initial gingivitis index of at least 1.0 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
- •Presence of orthodontic appliances.
- •Presence of partial removable dentures.
- •Tumor(s) of the soft or hard tissues of the oral cavity.
- •Moderate and/or advanced periodontal disease, rampant caries, or any condition that the dental examiner considers exclusionary from the study.
- •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 and/or drinking for periods up to 4 hours.
- •History of alcohol and/or drug abuse.
- •Self-reported pregnancy and/or lactating subjects.
研究组 & 干预措施
Group I
Meridol regimen comprises an amine base compound, zinc lactate and NaF (AZF) toothpaste and mouthwash, brush 2x day/2min and swish 15ml/30 secs after brushing
干预措施: Test Regimen (Drug)
Group I
Meridol regimen comprises an amine base compound, zinc lactate and NaF (AZF) toothpaste and mouthwash, brush 2x day/2min and swish 15ml/30 secs after brushing
干预措施: Control Regimen (Drug)
Group II
Regular fluoride toothpaste, Brush 2 x day 2 mins
干预措施: Test Regimen (Drug)
Group II
Regular fluoride toothpaste, Brush 2 x day 2 mins
干预措施: Control Regimen (Drug)
结局指标
主要结局
Quigley and Hein Plaque Index
时间窗: Baseline, 3 weeks, 6 week & 12 weeks
reductions in dental plaque
Loe and Silness Gingival Index
时间窗: Baseline, 3 weeks, 6 week & 12 weeks
assessment of gum problems (gingival scores)
次要结局
未报告次要终点