A Randomized, Parallel Design Study to Compare the Effects of A New Philips Sonicare Brush Head Versus Manual Toothbrush on Plaque and Gingivitis After a Six-Week Period of Home Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
研究概览
简要总结
The goal of this clinical trial is to learn if powered toothbrushing is more effective than manual toothbrushing in removing dental plaque. It will also learn about the safety of power toothbrushing. The main questions the study aims to answer are:
Does power toothbrushing remove more dental plaque than manual toothbrushing? Does power toothbrushing reduce symptoms of gingivitis better than manual toothbrushing?
Participants will:
Brush their teeth twice a day with either a manual or power toothbrush Visit the clinic twice during the study, after two and six weeks after the study starts.
Keep a diary of when they brushed their teeth
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Be willing and physically able to carry out all study procedures and be available at all times required for participation
- •Be able to fully understand and comply with the written and verbal instructions provided
- •Provide written informed consent
- •Willing to attend all study visits
- •Agree to return study materials at the required visit(s)
- •Between the ages of 18-65 years
- •A non-smoker
- •Minimum of 20 'scorable' teeth (excluding 3rd molars)
- •Average plaque score of >1.8 per Modified Plaque Index scoring with 3-6 hours of plaque accumulation
- •Gingival bleeding score of >1 on a minimum of 50 gingival sites per Gingival Bleeding Index
- •Regular manual toothbrush user
排除标准
- •Pregnant or nursing per subject report
- •A medical or dental condition that would be unduly affected by participation in this study, per Investigator discretion
- •A medical condition requiring antibiotic pre-medication prior to dental appointments
- •Diagnosis of xerostomia
- •Oral or extra oral piercing that interferes with the ability to perform study procedures and/or clinical assessments in the mouth
- •Currently undergoing or requiring dental/periodontal treatment, or having had periodontal treatment in the six months preceding the study, where the subject's study participation could present an undue safety risk or obscure the evaluation of study endpoints, per Investigator/Examiner discretion
- •Oral surgery within the last 2 months Currently using professionally dispensed bleaching products
- •A known allergy or sensitivity to products planned for use in this study
- •Unwilling to abstain from all other oral hygiene products other than those prescribed for the duration of the study
- •Participated in an oral care study within the previous 60 days
- •Employee or a relative of an employee of the Site clinical research department, dental school, or a dental products manufacturing, research or marketing firm
- •Dental student or dental professional
- •A cardiac pacemaker or implanted cardiac defibrillator
- •Insulin-Dependent Diabetes
- •Current use of antibiotic medications or use within 4 weeks of enrollment
- •Current use of prescription-dose anti-inflammatory medications or anticoagulants; (including aspirin > 81 mg daily)
- •Presence of advanced periodontal disease or excessive gingival recession, per Investigator/Examiner discretion
- •Heavy deposits of calculus, either supragingival and/or subgingival, per Investigator/Examiner discretion
- •Extensive crown or bridge work and/or rampant decay, per Investigator/Examiner discretion
- •Presence of orthodontic bands, wires or brackets
- •A professional prophylaxis within 4 weeks of the study
- •Regular power toothbrush user
研究组 & 干预措施
Power Toothbrush
Administered using Sonicare Power toothbrush with All-in-One brush head
干预措施: power toothbrush (Device)
Manual Toothbrush
Administered using Colgate Classic Adult Manual Toothbrush
干预措施: manual toothbrush (Device)
结局指标
主要结局
Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 6 weeks
时间窗: 6 weeks
Surface plaque measured by Lobene and Soparkar Modified Quigley-Hein Plaque Index (MPI) using six sites per tooth (distobuccal, buccal, mesiobuccal and distolingual, lingual, mesiolingual) where 0=no plaque, 1. separate flecks of plaque at the cervical margin of the tooth, 2. a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth, 3. a band of plaque wider than 1 mm covering less than one third of the crown of the tooth, 4. plaque covering at least one-third but less than two-thirds of the crown of the tooth, 5. plaque covering two-thirds or more of the crown of the tooth. Change in MPI will be calculated by subtracting follow-up MPI score from baseline MPI score. Differences in MPI will be compared between the manual and power toothbrush groups.
次要结局
- Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 2 weeks(2 weeks)
- Compare the reduction in surface plaque for power toothbrush to manual toothbrush after 2 weeks(2 weeks)
- Compare the reduction in gingivitis for power toothbrush to manual toothbrush after 6 weeks(6 weeks)
- Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 2 weeks(2 weeks)
- Compare the reduction in gingival bleeding for power toothbrush to manual toothbrush after 6 weeks(6 weeks)