The Effects of Using the Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush in Reducing Bleeding on Probing and Plaque Removal: A Randomized Control Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Change in bleeding on probing (BOP)
研究概览
简要总结
In this study, all subjects will be given an electric toothbrush. Half of the participants will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of participants will be asked to follow the brushing instructions in the user manual. The study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing bleeding on probing with the use of an electric toothbrush used without personal professional instruction.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •At least 18 years of age
- •Subjects must show > 20% buccal/lingual cervical sites with bleeding on probing (BoP)
- •Subjects must have > 24 natural teeth excluding third molars
- •Subjects must have had a professional dental prophylaxis within three months of beginning the study
- •Subjects must be willing to brush with electric toothbrush twice daily.
- •Subjects who are randomized into Group 1 must be willing to be taught and to demonstrate the SBTT
- •Subjects who are randomized into Group 2 must be willing to follow the Sonicare DFU from Philips Oral Healthcare; however, will otherwise be uninstructed until after the study has been completed
- •Subjects must be willing to refrain from any oral hygiene for at least 12-18 hours prior to each study follow-up visit.
排除标准
- •Subjects who use tobacco products
- •Subjects who are currently pregnant (self-reported) due to the greater bleeding tendency caused by hormonal changes
- •Subjects with fixed or removable orthodontic appliances
- •Subjects whose restorations violate or potentially violate the biologic width.
- •Subjects with irregular restoration margins or overhanging margins within 1mm of the crest of the marginal gingiva.
- •Antibiotic treatment at the time of the initial examination or during the month prior
- •Subjects with cervical probing depth >3 mm
- •Subjects with systemic diseases that affect the gingiva
- •Subjects taking medications that affect the gingiva
- •Subjects who cannot read/write/speak English
结局指标
主要结局
Change in bleeding on probing (BOP)
时间窗: Baseline through study completion, an average of 4 months
To compare the use of the SBTT with an electric toothbrush in reducing BOP with the use of an electric toothbrush used without personal professional instruction.
次要结局
- Effectiveness of professional cleaning(Baseline and 4 months)
- Change in plaque(Baseline and 4 months)
- Evaluating deformation of toothbrush bristles(Baseline through study completion, an average of 4 months)
研究者
Livia Valverde
Assistant Professor
Tufts University School of Dental Medicine