Evaluation of Safety and Efficacy of Bixdo Ultra Compact Water Flosser in Addition to Toothbrushing-A 8-week Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 1
- 主要终点
- Bacterial plaque removal
研究概览
简要总结
The objective of the present randomized controlled trial is to evaluate the safety and efficacy of the use of Bixdo A30 Pro Ultra Compact Water Flosser (also referred to as the "Bixdo A30 Portable Water Flosser Travel Set") in addition to a manual toothbrush on clinical parameters of inflammation and bacterial plaque removal.
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
- None
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
- 否
入选标准
- •Participants between the age of 18 - 70 years old.
- •Having at least 20 natural teeth in their dentition - excluding third molars.
- •In good overall systemic health, in the opinion of the investigator.
- •In good dental health with no visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
- •No hard or soft tissue lesions.
- •Subjects with moderate or severe plaque-induced gingivitis: a minimum of 50% BOP, 1.75 modified gingival index (MGI), and 0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm.
- •Subjects who agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns) for the duration of the study
- •For the main study only: Subjects who agree to refrain from using any non-study dental device or oral care products for the duration of the study, return for scheduled visits, and comply with all study procedures.
排除标准
- •Systemic disease self-reported that has an impact on periodontal status (e.g., diabetes mellitus, HIV/AIDS, rheumatoid arthritis).
- •History of any autoimmune disease (e.g., pSS, SLE, psoriasis, IBS).
- •History of immunosuppressive chemotherapy or history of any disease known to severely compromise immune function (e.g., cytomegalovirus infection) within the last 5 years.
- •Any acute intraoral infection (e.g., herpetic gingivostomatitis, herpangina, abscesses).
- •Patients with visible carious lesions, periodontitis, orthodontic appliances, or removable partial dentures.
- •Patients with mild plaque-induced gingivitis: < 50% BOP, <1.75 modified gingival index (MGI), and <0.60 Rustogi Modification of the Navy Plaque Index (RMNPI) and PPD ≤5 mm.
- •Patients with PPD >5 mm.
- •Need for antibiotic premedication for routine dental procedures.
- •Use of antibiotics within the last 3 months.
- •Daily use of steroids or non-steroid anti-inflammatory therapy within the last 3-months.
- •Patients who self-report pregnancy or lactation (hormonal changes that can affect periodontal health and aggravate existing periodontal disease).
- •Current smokers.
- •Inability or unwillingness to sign informed consent form.
- •Patients who do not agree to delay dental prophylaxis, elective dental treatment, and cosmetic procedures (i.e. tooth whitening, crowns).
- •For the main study only: Patients who do not agree to refrain from using any non-study dental device or oral care products, return for scheduled visits, and comply with all study procedures.
- •Anything that would place the individual at increased risk or preclude the individual's full compliance with or completion of the study at the discretion of the investigators.
- •For the main study only: Patients who need assistance from others to perform their daily oral hygiene practices or read the manual of instructions that come with the at-home product.
- •Those not fluent in English
研究组 & 干预措施
Interventional Group
Those randomized into the interventional group will be asked to use the Bixdo Ultra Compact Water Flosser twice a day for 8 weeks.
干预措施: Bixdo Ultra Compact Water Flosser (Device)
Control Group
Those randomized into the control group will be asked to only use the study provided manual toothbrush and toothpaste twice a day for 8 weeks.
干预措施: Manual toothbrush (Device)
结局指标
主要结局
Bacterial plaque removal
时间窗: 8 weeks
At each of the three study visits, subjects will be given dental plaque erythrosine disclosing agents (Sunstar GUM® RED-COTE®) to assess the level of plaque on the subjects teeth
Inflammation Reduction
时间窗: 8 weeks
At each of the three study visits, the examiners will conduct a periodontal clinical exam, following standard of care procedure, to evaluate the levels of inflammation in the gingiva of subjects in both the intervention and control groups.
次要结局
未报告次要终点