Utilization of a Periodontal Endoscope in Nonsurgical Periodontal Therapy: A Randomized, Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm
研究概览
简要总结
The purpose of this study was to compare the clinical outcomes of teeth deep cleaning or scaling and root planing (SRP) using a periodontal endoscope (Perioscopy®) versus traditional SRP using magnifying loupes for up to twelve months, utilizing a split mouth design.
详细描述
Twenty-five (25) patients were recruited for the study that exhibited mild to moderate periodontitis. SRP or deep cleaning was rendered by the same experienced hygienist, following random assignment of the left or right half of the mouth to either recieve deep cleaning by using a periodontal endoscope (Perioscopy®) or traditional deep cleaning using magnifying loupes. All the periodontal evaluations were done by the same periodontal resident at baseline, one month, three months, six months, and twelve months after deep cleaning.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Follow up re-evaluation visits were performed by the same resident ~1month, 3 months, 6 months, and 1 year, who was blinded to lknowing which side of the mouth recieved what type of deep cleaning treatment.
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
- •18 years of age or older
- •in good general health
- •given a diagnosis of mild-moderate generalized chronic periodontitis per the 1999 world workshop classification of periodontal diseases and conditions
- •required whole mouth SRP
- •teeth had a maximum of 6mm probing pocket depth at any site
- •at least one molar present in each arch, excluding third molars.
排除标准
- •any requirement for antibiotic premedication prior to dental treatment
- •uncontrolled hypertension
- •uncontrolled diabetes
- •subject unwilling to sign the informed consent
- •subject needed any antibiotic intervention for unrelated conditions
结局指标
主要结局
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm
时间窗: 3 months
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - probing pocket depth in mm.
时间窗: 12 months
Probing pocket depth (in mm) will be measured at six sites per tooth on all teeth per patient.
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - presence or absence of bleeding on probing.
时间窗: 12 months
The presence or absence of bleeding on probing will be meaured at six sites per tooth on all teeth per patient.
Percentage of periodontal sites that improved following use of loupes vs perioscopy from baseline - clinical attachment level in mm.
时间窗: 12 months
Clinical attachment level (in mm) will be measured at six sites per tooth on all teeth per patient.
次要结局
- Comparison of clinical measures of periodontal status of teeth (probing pocket depth) of subgroups of teeth following treatment with loupes vs perioscopy.(12 months)
- Comparison of clinical measures of periodontal status of teeth (clinical attachment level) of subgroups of teeth following treatment with loupes vs perioscopy.(12 months)
- Comparison of clinical measures of periodontal status of teeth (bleeding on probing) of subgroups of teeth following treatment with loupes vs perioscopy.(12 months)