The Impact of a Modified Probe Tip Design on Patient Perception of Discomfort on Probing and Clinical Parameters Using the Florida Probe® System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- VAS (visual analogue scale) value 0-100mm
研究概览
简要总结
Patient perception of pain on periodontal probing using a controlled-force, electronic probe was not significantly affected by the use of a modified (ball-end) probe tip design except for in the maxilla, where a standard straight probe tip appeared to be more comfortable for patients.
详细描述
Recordings of periodontal probing pocket depth (PPD) and probing attachment level (PAL) are utilized in diagnosis of periodontal disease and monitoring of disease progression. Manual probing presents reproducibility and accuracy issues based on features such as probe tip design, force applied by the operator and inflammatory status of the periodontal tissues. Evidence from the literature suggests that some patients may determine periodontal probing to be a painful experience.
The aims of this study are to evaluate the suitability of a new titanium probe tip for periodontal probing, and to evaluate pain on periodontal probing, in comparison to the existing probe tip used in the Florida Probe® system.
The study will be a randomized, blinded, split-mouth controlled trial. Twenty (20) consecutive patients meeting the inclusion criteria will be selected to undergo full-mouth periodontal probing. One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip; the opposing jaw will be probed using the new trial tip. At a second visit (within 2 weeks), prior to treatment, the mouth will be probed once again, alternating the jaws from the first visit.
On each occasion, patients will report on pain on probing utilizing two ungraded 100mm horizontal visual analogue scales (VAS) representing upper and lower jaws of the mouth.
Periodontal probing depth measurements will be compared to assess the reproducibility of the two probe tips.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 盲法
- Single (Participant)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Ball Tip Probe
One half (upper or lower jaw) of the mouth will be probed using the new trial tip (ball-end probe, 0.6mm diameter).
干预措施: Ball Tip Probe (Device)
Florida Probe Straight Tip Probe
One half (upper or lower jaw) of the mouth will be probed using the current, standard probe tip (straight-end probe, 0.45mm diameter).
干预措施: Florida Probe Straight Tip Probe (Device)
结局指标
主要结局
VAS (visual analogue scale) value 0-100mm
时间窗: 2 weeks
Patients will report on pain on probing utilizing two ungraded 100mm horizontal visual analogue scales (VAS): line with values from 0-100, where 0 is no pain and 100 is the worst possible pain, representing upper and lower jaws of the mouth. Periodontal probing depth measurements will be compared to assess the reproducibility of the two probe tips.
次要结局
未报告次要终点