Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 2
- 主要终点
- "Periodontal pocket closure"
研究概览
简要总结
Treatment directed towards the control of periodontal infections is to about 90% non-surgical procedures. There is evidence from a large number of randomized controlled studies that the efficacy in terms of clinical outcomes of a full-mouth ultrasonic debridement approach (FMUD) is comparable to that of traditional section-wise scaling and root planing (SRP). A hypothesis for the current effectiveness study is that comparable clinical effects will be obtained with the FMUD approach as with conventional section-wise SRP, but with significantly more favourable patient-centred and health-economic outcomes.
This randomized study involves about 100 professionals (dental hygienists) and more than 850 patients at 40 dental clinics in the Vastra Gotaland Region, Sweden. The project not only evaluate treatment effects in terms of pertinent clinical outcomes, it also has a strong focus on patient-centered measures - patient-reported experience measures (PREM) and patient-reported outcome measures (PROM) - as well as health-economics.
详细描述
All patients with chronic periodontitis (age 30 years and older) attending the selected Public Dental clinics in VG are eligible. The patients should have at least 8 teeth with pathological pockets (probing pocket depth ≥5 mm and bleeding on probing). Only patients providing signed informed consent are included.
Reported data in the study by Wennström et al. (J Clin Periodontol 2005) were used for power calculation. Thus, a total sample of 834 patients will provide a power of 95% at a significance level of p<0.05 to detect a difference of 5% in proportion of sites with "pocket closure" i.e. PPD ≤4 mm and BoP negative (primary efficacy variable) between treatment groups. For a power of 80% a total sample of 506 patients is required.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic periodontitis
- •at least 6 teeth with approximal probing pocket depth ≥5 mm and bleeding on probing
排除标准
- •subgingival instrumentation within 6 months prior to screening examination
- •compromised medical conditions requiring prophylactic antibiotic coverage
结局指标
主要结局
"Periodontal pocket closure"
时间窗: Up to 18 months
Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding
次要结局
- Bleeding on pocket probing (BoP)(Up to 18 months)
- Patient-reported experience measures (PREM)(Up to 18 months)
- Investment for treatment(Up to 18 months)
- Probing pocket depth(Up to 18 months)
- Patient-reported outcome measures (PROM)(Up to 18 months)