NCT02980497已完成不适用
Determination of the Antiplaque/Antigingivitis Efficacy of Essential Oil Containing Mouthrinses In a Six-Month Study
Johnson & Johnson Consumer and Personal Products Worldwide2 个研究点 分布在 1 个国家目标入组 370 人开始时间: 2013年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 370
- 试验地点
- 2
- 主要终点
- Mean Modified Gingival Index (MGI) at 6 Months
研究概览
简要总结
The objective of this randomized, single-center, examiner-blind, controlled, parallel group, six-month clinical study is to compare the antiplaque/antigingivitis potential of a no-alcohol essential oil containing mouthrinse and an alcohol essential oil containing mouthrinse. A negative control group using only an ADA Accepted anticavity toothpaste will be included.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females 18 years of age or older, in good general and oral health, except gingivitis.
- •Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates) based upon research site personnel's assessment;
- •Evidence of a personally signed and dated informed consent document indicating the subject (or legally acceptable representative) has been informed of all pertinent aspects of the trial.
- •A minimum of 20 natural teeth with scorable facial and lingual surfaces. Teeth that are grossly carious, extensively restored, orthodontically banded, abutments, exhibiting severe generalized cervical and/or enamel abrasion, or third molars will not be included in the tooth count.
- •A mean gingival index ≥ 1.75 according to the Modified Gingival Index.
- •A mean plaque index ≥ 1.95 according to the Turesky modification of the Quigley-Hein Plaque Index scored on six surfaces per tooth.
- •Absence of significant oral soft tissue pathology, excluding plaque-induced gingivitis, based on a visual examination and at the discretion of the Investigator.
- •Absence of moderate/advanced periodontitis based on a clinical examination (ADA Type III, IV).
- •Absence of fixed or removable orthodontic appliance or removable partial dentures.
排除标准
- •History of significant adverse effects, including sensitivities or suspected allergies, following use of oral hygiene products such as toothpastes and mouthrinses and red food dye.
- •History of serious medical conditions that, at the discretion of the Investigator, will disqualify the subject.
- •History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
- •Antibiotic, anti-inflammatory or anticoagulant therapy during the study or within the 2 weeks prior to the baseline exam.
- •Regular use of chemotherapeutic antiplaque/antigingivitis products such as triclosan, essential oil, cetylpyridinium chloride, or chlorhexidine containing mouthrinses within the 2 weeks prior to baseline.
- •Current or history of alcohol or drug abuse.
- •Self reported pregnancy or lactation (this is an exclusion criterion due to oral tissue changes related to pregnancy and nursing which can affect interpretation of study results).
结局指标
主要结局
Mean Modified Gingival Index (MGI) at 6 Months
时间窗: 6 Months
Gingivitis was assessed on the buccal and lingual marginal gingivae and interdental papillae on all scoreable teeth on a 5-grade categorical scale of 0=normal to 4=severe inflammation.
次要结局
- Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 1 Month(1 Month)
- Mean Modified Gingival Index (MGI) at 1 Month(1 Month)
- Mean Gingival Bleeding Index (BI) at 1 Month(1 Month)
- Mean Gingival Bleeding Index (BI) at 6 Months(6 Months)
- Mean Modified Gingival Index (MGI) at 3 Months(3 Months)
- Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 3 Months(3 Months)
- Mean Gingival Bleeding Index (BI) at 3 Months(3 Months)
- Mean Plaque Index (PI) (Turesky Modification of the Quigley Hein PI) at 6 Months(6 Months)
研究者
研究点 (2)
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