Efficacy of Philips Sonicare Flexcare Platinum Toothbrush® Compared to Manual Brushing in Healthy Patients: a 1 Year Follow up
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 2
- 主要终点
- Change in Plaque Index (PI)
研究概览
简要总结
Professional oral hygiene has become a customary procedure in everyday dentistry. Both manual and sonic brushes are part of normal oral hygiene education practice. Compared with manual toothbrushes, ergonomic instruments, such as sonic toothbrushes, can be a more practical and less demanding mean to remove biofilm and plaque efficiently. Studies in literature investigate the efficacy of toothbrushes in plaque removal, but the investiagator's study would validate efficacy of toothbrushes post-causal therapy, towards lower plaque accumulation, and reduction in bleeding.
The objective of this study is to compare two methods (manual VS sonic) of tooth brushing in terms of impact on the gingival index and plaque index after one session of Full Mouth-Erythritol Powder Air Polishing Therapy (FM-EPAPT) in healthy patients.
The hypothesis of the present randomized controlled trial is that sonic tooth brushing accumulates less plaque (-10%) than manual tooth brushing.
To test this hypothesis, the patients, upon initial evaluation, will be divided in 2 study groups and, after a session of professional oral hygiene, will be instructed to use:
- CONTROL: manual toothbrush
- TEST: sonic toothbrush. Gingival index and plaque score will be evaluated at 2, 4, 6 weeks and 6 and 12 months.
详细描述
Everyone's goal to have a healthy mouth is the removal of biofilm, plaque and calculus from the dental surface everyday. Moreover routine recalls ensure a better oral health and greater protection against caries, gingivitis and periodontitis. Regular attendance to oral hygiene sessions plays an important role but has to be accompanied by the compliance with home oral care instructions. The patients should be adequately instructed to take care of their oral health.
TRIAL DESIGN: Monocetric, pragmatic, single blinded, randomized clinical trial (RCT) of parallel design.The trial will have one-year duration.
STUDY POPULATION: Healthy subject affected by gingivitis are included in the study. Presence of gingivitis is defined as bleeding on probing (BOP) > 25%.
PRIMARY OUTCOME: Change in Plaque Index (PI): change in 10% less of the site in test group.
SECONDARY OUTCOME:
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients affected by gingivitis is defined as bleeding on probing (BOP) > 25%.
- •Healthy young patients (18-40 years)
- •Patients with almost 5 teeth per quadrant
- •Patients smoking less than 10 cigarettes a day
排除标准
- •Presence of periodontitis (pocket depth - PPD > 4 mm)
- •Patient with BOP and/or plaque index < 25%
- •Patient with any systemic disease
- •Orthodontic or prosthesis patient
- •Patient with split
- •Impossibility to come to the recall appointments
- •Not willing to follow the agreed protocol
结局指标
主要结局
Change in Plaque Index (PI)
时间窗: Baseline, 2, 4, 6 weeks and 6, 12 months
Change in percentage of site with plaque. Baseline values will be compared to the values recorded in the follow-up visits. Change in 10% of the site in test group. 10% site modification in favor of the test group.
次要结局
- Change in CAL (Clinical Attachment Level)(Baseline 6, 12 months)
- Change in Gingival Index (GI)(Baseline, 2, 4, 6 weeks and 6, 12 months)
- Change in REC (Clinical Gingival Recession)(Baseline 6, 12 months)
研究者
Magda Mensi
Principal investigator
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia