Impact of Timing of Re-evaluation After Non-surgical Periodontal Therapy on Clinical Parameters and Decision-making. A Prospective Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 28
- 试验地点
- 2
- 主要终点
- Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
研究概览
简要总结
Literature on non surgical periodontal therapy (NSPT) shows lack of clarity in reporting information on re-evaluation timing and clinical response. If the re-evaluation was done shortly after NSPT, this is also likely to have an influence on the surgical treatment plan. The aim of this prospective clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, PD reduction, comprehensive treatment plan, and costs for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Periodontitis stage III-IV
- •Full-mouth plaque score (FMPS) < 25% at the 1-month re-evaluation
- •Full-mouth bleeding score (FMBS) < 25% at the 1-month re-evaluation
- •Signed informed consent
排除标准
- •Age < 18 yo
- •Pregnancy or lactation
- •Heavy smokers (>10 die)
- •Conditions or diseases influencing periodontal healing
- •Patients that cannot complete the 6 months follow-up
结局指标
主要结局
Change in pocket closure % (0 - 100 % with higher percentage indicating better status)
时间窗: [Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.]
Percentage of pockets ≥ 5 mm that converted to ≤4 mm at the completion of NSPT
次要结局
- Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes.([Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.])
- Change in Full Mouth Plaque Score (FMPS%) (0 - 100 % with higher percentage indicating worse status)([Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.])
- Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes.([Time Frame: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.])
- Monetary cost for the treatment plan in €([Time Frame: 1 month, 3 months and 6 months after the completion of the therapy.])