Randomized Double Blind Controlled Prospective Study to Evaluate the Influence of Radiofrequency Based Toothbrush on the Accumulation of the Calculus
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Change in Plaque score %
研究概览
简要总结
to evaluate the influence of radiofrequency based toothbrush (Silk'n toothwave)on the accumulation of the calculus
详细描述
Calculus is a white-brownish layer with various levels of stiffness, which accumulates on teeth and is formed by the mineralization of dental plaque.
Thus, maintaining oral hygiene and adhering to maintenance programs keep low levels of plaque and calculus.
The electromagnetic field is known for bone healing by lessening osteoclast activity, improving osteoid formation, and stimulating angiogenesis. Furthermore, the electromagnetic field has an antimicrobial effect.
Electric toothbrushes have shown a statistical reduction in plaque accumulation and gingival inflammation.
Previous studies have shown that Silk'n Toothwave results in less plaque accumulation and calculus formation, in addition to stain removal and teeth whitening.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female patient aged 20-85 Years old
- •Subject must have voluntarily signed the informed consent form before any study related action
- •Presence of gingival inflammation (Gingival Index by Silness and Loe 1969)
- •Presence of plaque on clinical crowns (calculation of area)
- •Supportive periodontal therapy (with ultra-sonic and manual devices) on a regular basis with a 3-month interval with a minimum of 3 times in a row prior to T0 (baseline)
- •Compliance with study schedules and arrival at study visits
排除标准
- •A systemic or pharmacological condition that can affect the healing of soft or hard tissue in the rest of the teeth or implants such as cyclosporine, calcium channel blockers
- •Pregnant or lactating women (*If Male Please write N/A).
- •Heavy smokers (more than 10 cigarettes per day).
- •Patients with a pacemaker that do not allow the use of an ultrasonic device.
- •Patient with an active periodontal disease (may undergo periodontal treatment as required and not completed as part of the study if it can be included in the study).
- •Systemic condition requiring prophylactic antibiotics.
- •Patients taking NSAIDS for prolonged period.
研究组 & 干预措施
Test group: Silk'n Toothwave with vibration and electromagnetic field
Silk'n Toothwave with vibration and electromagnetic field use twice a day for 3 months.
干预措施: Silk'n Toothwave (Device)
Control group: Silk'n Toothwave with-out an electromagnetic field ( only vibration)
Silk'n Toothwave without an electromagnetic field (only vibration ) use twice a day for 3 months.
干预措施: Silk'n Toothwave (Device)
Silk'n Toothwave with an electromagnetic field and without vibration
Silk'n Toothwave with an electromagnetic field and without vibration use twice a day for 3 months.
干预措施: Silk'n Toothwave (Device)
结局指标
主要结局
Change in Plaque score %
时间窗: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
to estimate the presence of plaque and its accumulation on the tooth surface of anterior mandibular incisors
Change in Calculus ratio %
时间窗: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
to estimate the percentage of calculus on the lingual aspect of anterior mandibular incisors using ImageJ software
Change in Free gingival margin color (CEILAB color space)
时间窗: baseline (T0), after 4 weeks (T1), after 12 weeks (Tf)
the color of the gingiva will be measured with the software Adobe photoshop and will be calculated with CIELAB color space.
次要结局
- Probing depth mm(baseline (T0), after 4 weeks (T1), after 12 weeks (Tf))
- Bleeding on probing Yes/No(baseline (T0), after 4 weeks (T1), after 12 weeks (Tf))
- Recession mm(baseline (T0), after 4 weeks (T1), after 12 weeks (Tf))
- Subject satisfaction questionnaire(4 weeks (T1), after 12 weeks (Tf))