Assessing Three Oral Care Regimen on Plaque, Gingivitis, and Tooth Whitening
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Tooth Whitening Shade Evaluation
研究概览
简要总结
Assessing the effects of three oral care regimen on plaque, gingivitis, and tooth whitening: A randomized, person-centric, comparative effectiveness clinical research study by the Practitioners Engaged in Applied Research and Learning (PEARL) Network.
详细描述
Six month, five visit study of plaque, gingivitis, and tooth whitening with three randomized intervention groups using FDA marketed and approved products and devices. One hundred fifty (150) subjects from the patient base of 10 PEARL Network associated dental offices on the East Coast of the United States will be entered into the clinical research study. This is a post-marketing comparative effectiveness research study. Having a total of 5 visits over a six month period. Adverse events and side effects for the products used are being assessed.
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, 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
- •Subject males or females 18 to 70 years old (inclusive).
- •Availability for the 6 months duration of the clinical research study
- •Good general health
- •Subject able and willing to follow study procedures and instructions
- •Subject read, understood and signed an informed consent form
- •Subject present with at least 20 natural teeth in the functional dentition (excluding third molars), including the following natural (uncrowned) teeth for shading: #6, #7, #8, #9, #10, #11
排除标准
- •Potential subjects must NOT HAVE ANY of the following conditions:
- •Presence of orthodontic bands
- •Presence of partial removable dentures
- •Tumor(s) of the soft or hard tissues of the oral cavity
- •Restorations or crowns that would interfere with color measurements on the following teeth: #6, #7, #8 , #9, #10 & #11 (upper six front teeth)
- •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 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
- •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 which prohibits eating or drinking for periods up to 4 hours
- •History of alcohol or drug abuse
- •Pregnant or lactating
研究组 & 干预措施
Whitening Dentifrice
干预措施: Toothbrushing (Other)
Whitening Dentifrice
干预措施: Fluoridated Dentifrice Whitening System (.454% stannous fluoride with 2% hydrogen peroxide) (Other)
Dentifrice
干预措施: Toothbrushing (Other)
Dentifrice
干预措施: Fluoridated Dentifrice (.15% sodium monofluorophosphate) (Other)
Whitening and Dentifrice
干预措施: Toothbrushing (Other)
Whitening and Dentifrice
干预措施: Whitening (4.5% hydrogen peroxide) (Other)
Whitening and Dentifrice
干预措施: Other Fluoridated Dentifrice (.454% stannous fluoride) (Other)
结局指标
主要结局
Tooth Whitening Shade Evaluation
时间窗: 6 months
次要结局
- Patient Questionnaire(6 months)
- Plaque Index(6 months)
- Gingival Index(6 months)