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临床试验/NCT07724054
NCT07724054已完成不适用

Oral Hygiene Access in Patients With Dental Implants Using Two Toothbrushes: A Randomized Crossover Clinical Trial

Octavi Camps-Font1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2024年5月18日最近更新:
适应症
干预措施

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

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

Active Comparator

Plaque removal with a medium-textured toothbrush

干预措施: Plaque removal (Other)

Polybutylene terephthalate (PBT) tapered-end toothbrush

Experimental

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

发起方
Octavi Camps-Font
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Octavi Camps-Font

Associate professor

University of Barcelona

研究点 (1)

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