Impact of a Full-mouth Electronic Toothbrush on Indicators of Gingivitis and Patient Perceptions: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 2
- 主要终点
- Löe & Silness gingival index (GI)
研究概览
简要总结
The goal of this randomized, masked-examiner clinical trial is to investigate a full-mouth electronic toothbrush (FMET). The three arms are: 1) FMET + American Dental Association (ADA) approved dentifrice, 2) conventional electronic toothbrush (ETB) + ADA dentifrice and 3) FMET + foam system.
详细描述
The primary purpose is to compare the FMET + ADA dentifrice to the conventional ETB + ADA dentifrice. The exploratory aim is to compare the FMET + foam system to both the FMET + ADA dentifrice and conventional ETB + ADA dentifrice. Baseline and 30-day outcome measures will be collected to evaluate the impact on clinical indicators of gingivitis, plaque, and patient perceptions.
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 (Outcomes Assessor)
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
- •University of Minnesota School of Dentistry patient of record who is 18 years of age or older.
- •Documented periodontal classification of mild to moderate gingivitis (>10% BOP) or documented gingivitis on an intact, reduce, or stable with a history of periodontitis in AxiUm electronic health record (EHR) >10% BOP.
- •A minimum of 25% plaque measured O'Leary plaque score.
- •A minimum of five natural teeth in each quadrant (excluding third molars, dental implants or teeth with more that ½ of natural surface restored).
- •Be willing to abstain from all professional oral hygiene care (prophy/periodontal maintenance) during the study.
- •Be willing to abstain from the use of any other dental cleaning aids (dental floss, water flossers, interdental brushes, dental or tooth picks, mouthwash, etc.) during the study.
- •Access to personal email account and a device connected to the internet to complete questionnaires and communicate with study team.
排除标准
- •Presence of aggressive, necrotizing, uncommon periodontal disease, or any uncontrolled periodontal condition.
- •Presence of any physical limitation or restriction that might preclude normal oral hygiene procedures (i.e. need another individual to perform oral self-care).
- •Fixed prosthesis (i.e. implant retained denture), orthodontic appliance or under orthodontic treatment.
- •Any medication that may impact periodontal conditions (i.e., phenytoin, calcium antagonists, cyclosporin, warfarin, antimicrobials, or steroids).
- •Have any uncontrolled medical condition or immunocompromised that may impact the study (i.e. uncontrolled diabetes HbA1c > 7, HIV).
- •Pregnant, planning to become pregnant, or unsure of pregnancy status (self-reported)
- •≥2 weeks of antibiotic use in the past three months. Or antibiotic use in the last six weeks.
- •Cigarette use within the last year
- •Unable to comply with the study protocol
结局指标
主要结局
Löe & Silness gingival index (GI)
时间窗: Baseline and 30-days
Scale 0-3
Turesky modification of the Quigley-Hein index
时间窗: Baseline and 30-days
Scale 0-5
次要结局
未报告次要终点