The Effects of Interactive Powered Toothbrush With Application-assisted on Plaque, Gingivitis and Gingival Abrasion: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 主要终点
- Bleeding on marginal bleeding index (BOMP) index measurement
研究概览
简要总结
It has been suggested that interactive power toothbrushes (PTBs), developed in recent years, provide more successful results in plaque control and effective use of brushing time by enabling patient collaboration and self-treatment, thanks to the application features associated with mobile phones. Interactive PTB synchronized with smartphones, including real-time feedback, session length, applications that prevent excessive brushing force, and focus brushing on specific areas with position detection technology, increases the brushing performance by increasing oral hygiene motivation.
Studies report that both power and manual toothbrushes cause gingival abrasion, a localized reversible lesion of the epithelium. While the opinions about the cause of gingival abrasion are not clear yet, the discussions regarding brush strength yet continue. While it is possible to control the interactive PTB force thanks to the mobile application, it is known that these high-speed rotating brushes control plaque effectively, but there is not enough evidence about its effect on gingival abrasion.
The primary purpose of this clinical study is to determine whether interactive PTB with application feature provides an additional benefit on plaque removal efficacy and reduction of gingival inflammation. In addition, this study aims to determine the effect of interactive power toothbrush with application on gingival abrasion by comparing it to interactive PTB without application and manual toothbrush. The study's null hypothesis in terms of gingival abrasion is that interactive PTB do not show a significant difference from other brushing methods.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The examiner who performed clinical periodontal parameters was blinded to group assignment.
入排标准
- 年龄范围
- 18 Years 至 25 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Dental students
- •Diagnosed with gingivitis
- •Clinical measurements: Probing pocket depths ≤3 mm, QHPI-TM ≥ 1.75 and with a bleeding site of at least 40% or more
- •Aged between 18-25
- •Non-smoker
- •No systemic diseases
- •Not undergoing orthodontic treatment
- •No crowding
- •No periodontal treatment in the last three months
排除标准
- •Use of power toothbrush before
- •Use of drugs that may affect the gingival tissues
- •Having mucogingival problems
- •Having carious teeth that require urgent treatment
- •Probing pocket depths ˃ 3mm
研究组 & 干预措施
Oral-B Genius® 8000 power toothbrush with Cross Action brush head with smartphone app for 8 weeks
Interactive PTB with Bluetooth® 4.0 connectivity smartphone app with Cross Action brush head using visually position detection feature. A triple pressure control system stops vibration, gives a visual warning, and reduces rotation speed in Daily Cleaning Mode-1.
干预措施: Oral-B Genius® 8000 power toothbrush with CrossAction brush head with smartphone app(Procter&Gamble,Ohio, USA) (Device)
Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app for 8 weeks
PTB without Bluetooth® 4.0 connectivity without smartphone app with Cross Action brush head without using visually position detection feature triple pressure control system stops vibration, provides visual warning and reduces rotation speed. The group was asked to use PTB with daily cleaning mode 1 and brush head, but without using the Bluetooth app (without using the position detection system).
干预措施: Oral-B Genius® 8000 power toothbrush with CrossAction brush head without smartphone app(Procter&Gamble,Ohio, USA) (Device)
Manual toothbrush: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) for 8 weeks
They were instructed to brush according to the Modified Bass technique.
干预措施: Oral B ClinicLine Pro-FlexSoft (Procter&Gamble,Ohio, USA) (Device)
结局指标
主要结局
Bleeding on marginal bleeding index (BOMP) index measurement
时间窗: 8 weeks
The presence/absence and amount of bleeding were graded on a 0-2 scale within 30 seconds of probing by probing the gingival margin at an angle of approximately 60 to the long axis of the tooth (0 = no bleeding, 1 = punctate bleeding, 2 = excessive bleeding).
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
时间窗: 8 weeks
Tooth surfaces stained with Mira-2 Toneblue® were evaluated with six different scores: Score 0 = No plaque, Score 1 = Plaque stains on the cervical edge of the tooth, Score 2 = A thin, continuous strip of plaque (up to 1 mm) at the cervical edge of the tooth, Score 3 = band of plaque wider than 1 mm but covering less than one-third of the dental crown, Score 4 = Plaque covering at least one-third but less than two-thirds of the dental crown, Score 5 = Plaque covering two-thirds or more of the dental crown.
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
时间窗: 8 weeks
Blue or purple visible abrasions were classified by measuring with a Williams periodontal probe placed along the long axis of the lesions ("small" if ≤2 mm, "moderate" if ≥3 mm and ≤5 mm, and "large" if \>5 mm).
Turesky modification of the Quigley-Hein Plaque Index (QHPI-TM) index measurement
时间窗: 2 weeks
Tooth surfaces stained with Mira-2 Toneblue® were evaluated with six different scores: Score 0 = No plaque, Score 1 = Plaque stains on the cervical edge of the tooth, Score 2 = A thin, continuous strip of plaque (up to 1 mm) at the cervical edge of the tooth, Score 3 = band of plaque wider than 1 mm but covering less than one-third of the dental crown, Score 4 = Plaque covering at least one-third but less than two-thirds of the dental crown, Score 5 = Plaque covering two-thirds or more of the dental crown.
Bleeding on marginal bleeding index (BOMP) index measurement
时间窗: 2 weeks
The presence/absence and amount of bleeding were graded on a 0-2 scale within 30 seconds of probing by probing the gingival margin at an angle of approximately 60 to the long axis of the tooth (0 = no bleeding, 1 = punctate bleeding, 2 = excessive bleeding).
Staining with Mira-2 Toneblue® to detect the gingival abrasion scores
时间窗: 2 weeks
Blue or purple visible abrasions were classified by measuring with a Williams periodontal probe placed along the long axis of the lesions ("small" if ≤2 mm, "moderate" if ≥3 mm and ≤5 mm, and "large" if \>5 mm).
次要结局
- Brushing times(8 weeks)
- Questionnaire(8 weeks)
研究者
Sühan Gürbüz
Principal Investigator
Gazi University