Timing of Re-evaluation After Steps I-II of Periodontal Therapy: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in treatment success % (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 randomized clinical trial is to investigate the effect of re-evaluation timing at 1-3-6 months after NSPT in terms of pocket closure, probing pocket depth reduction, comprehensive treatment plan, and costs for the patient.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, 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
- 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 treatment success % (0 - 100 % with higher percentage indicating better status)
时间窗: Baseline, 1 month, 3 months and 6 months after the completion of the therapy.
Percentage of pockets ≥ 4 mm with bleeding that converted to ≤ 3 mm or ≤4 mm without bleeding at the completion of non-surgical periodontal therapy
次要结局
- Change in Clinical Attachment Level (CAL) (0 - 15 mm with higher values indicating worse outcomes).(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)(Baseline, 1 month, 3 months and 6 months after the completion of the therapy.)
- Change in Probing Pocket Depth (PD) (0 - 15 mm with higher values indicating worse outcomes).(Baseline, 1 month, 3 months and 6 months after the completion of the therapy.)