Oral Hygiene Access in Patients With Dental Implants Using Two Toothbrushes: A Randomized Crossover Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Changes in the number of plaque-stained surfaces
研究概览
简要总结
Peri-implant mucositis is a reversible inflammatory condition primarily caused by biofilm accumulation around dental implants. Effective plaque control is essential for disease resolution; however, the influence of toothbrush bristle design on plaque removal around implant-supported prostheses remains unclear. Polybutylene terephthalate (PBT) tapered-end bristles are more flexible than conventional medium-textured bristles and may improve access to peri-implant areas while increasing patient comfort. This study aims to compare the effectiveness of a PBT tapered-end toothbrush and a medium-textured toothbrush in plaque removal, peri-implant bacterial load reduction, and patient-reported outcomes in individuals with peri-implant mucositis. Each participant will use both toothbrushes in a randomized sequence separated by a six-week washout period. Visible plaque will be disclosed and quantified using standardized photographic analysis based on the Rustogi Modified Navy Plaque Index. Absolute and relative peri-implant bacterial loads of Porphyromonas gingivalis and Fusobacterium nucleatum, together with total bacterial load, will be quantified by quantitative polymerase chain reaction. Patient satisfaction, including perceived discomfort, comfort, ease of handling and intention to use, will be assessed using visual analogue scales.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 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
- 否
入选标准
- •Adults diagnosed with peri-implant mucositis according to the 2017 World Workshop Classification.
- •Presence of a screw-retained implant-supported prosthesis comprising one to three crowns.
- •Attendance at the Implant Maintenance Unit during the recruitment period.
排除标准
- •Use of systemic antibiotics or antiseptic mouthrinses within the previous month.
- •Diagnosis of peri-implant health or peri-implantitis.
- •Special healthcare needs, mobility impairment, or cognitive/psychiatric disorders preventing adequate oral hygiene.
研究组 & 干预措施
Medium-textured toothbrush
Plaque removal with a medium-textured toothbrush
干预措施: Plaque removal (Other)
Polybutylene terephthalate (PBT) tapered-end toothbrush
Plaque removal with a Polybutylene terephthalate (PBT) tapered-end toothbrush
干预措施: Plaque removal (Other)
结局指标
主要结局
Changes in the number of plaque-stained surfaces
时间窗: Inmediately after the intervention
次要结局
- Absolute and relative counts of Porphyromonas Gingivalis and Fusobacterium Nucleatum(When the microbiological samples were analyzed)
- Total bacterial load quantified using universal 16S rDNA primers(When microbial samples were analyzed)
- Satisfaction questionnaire scores(Inmediately after the intervention)
研究者
Octavi Camps-Font
Associate professor
University of Barcelona
