Effect of a Multi-directional Power and a Manual Toothbrush in Subjects Susceptible to Gingival Recession: A 12-month Randomized Controlled Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 110
- 主要终点
- Bristle Splay Index (BSI) After a Specific Time-of-use
研究概览
简要总结
Background: Clinical studies have explored the relationship between toothbrushing and the development of recession, but relevant recession data for the multi-directional power toothbrush (PT) are lacking. The aim of this study was to evaluate the effect of brushing with either a multi-directional power toothbrush (PT) or an ADA (American Dental Association) reference manual toothbrush (MT) on pre-existing mid-buccal gingival recession (Pre-GR) over 12 months
Methods: This was a 12-month, prospective, single-blind, parallel-group, randomized controlled clinical study. Healthy participants without periodontitis but with at least 2 teeth showing Pre-GR ≥2mm were randomized to a group either brushing with a MT or a PT. The primary outcome parameter was the change at sites with Pre-GR ≥2mm. All recession measurements were performed by one calibrated examiner at baseline, 6 and 12 months. Secondary outcomes were changes of recession at all buccal sites (with or without pre-GR), changes in the percentage of recession sites demonstrating a change of ≥1mm as well as changes in pocket probing depths.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 scorable teeth without orthodontic appliances or crowns and bridges
- •at least 2 teeth showing recession of ≥ 2 mm on the mid-buccal surfaces (high risk teeth)
排除标准
- •evidence of neglected dental health
- •periodontitis and/or major hard/soft tissue lesions
- •any physical limitations or restrictions potentially interfering with normal oral hygiene
- •therapy with any drug within 28 days prior to the study
- •pregnancy or breast feeding
- •any systematic condition or significant illness
结局指标
主要结局
Bristle Splay Index (BSI) After a Specific Time-of-use
时间窗: 3, 6, 9 and 12 months
A digital computer program (ImageJ, NIH, Bethesda, MD, USA) for evaluating the index was applied. All brushes were photographed from both top and side view in a standardized set-up including a benchmark (Lego GmbH (Gemeinschaft mit beschränkter Haft), Grasbrunn, Germany) as reference for measurement. Subsequently, an independent examiner (N.H.) measured the lengths twice. To devise the BSI formula the results were averaged and inserted. The formula is defined by: BSI (%) = ((a´- a)/a + (b´- b)/b + (c´- c)/c + (d´- d)/d)/4 x 100. BSI was standardized for usage time by dividing it by the number of days used (BSI/T).
Gingival Recession at Sites With Preexisting Recessions ≥2mm
时间窗: 12 months
次要结局
- Comparison of BSI Between Periods(0-3, 9-12 months)
- Recession at All Buccal Sites(12 months)
- Percentage of Recession Sites Demonstrating a Change of ≥1mm(12 months)
- Pocket Probing Depths at 12months(12 months)
研究者
Sonja Sälzer
Dr. Sonja Sälzer
University Hospital Schleswig-Holstein