Outcomes of Traditional and Medical Models of Periodontal Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 2
- 主要终点
- Tooth loss
研究概览
简要总结
The purposes of this study are to:
- compare the clinical effectiveness of a traditional and a medical model of periodontal therapy; and
- determine the value of the two approaches to periodontal therapy.
详细描述
This application was developed to test the following hypothesis: A medical model of periodontal therapy, when compared to a traditional model, is as clinically effective, is more valuable, and can be realistically implemented in clinical practice. To accomplish this task a prospective, blinded, community based, cohort trial will be carried out. Two analytical techniques will be employed to compare the outcomes of periodontal therapy: clinical effectiveness and value. The two primary outcome variables for assessing clinical effectiveness will be clinician centered (attachment level) and patient centered (quality of life). The key outcome variable for value determination is cost of care. Value is then determined by dividing the outcome by the cost of care. Thus a similar outcome at reduced cost increases value. This facilitates calculating cost-effectiveness and cost-utility of care, preparing decision analysis trees, and carrying out sensitivity analysis.
There are two significant reasons for testing a medical model of care. If the hypothesis is correct:
- this would increase access to periodontal care; and
- it would offer a cost-effective method to treat periodontal infections that are correlated with systemic health problems.
These points argue for a direct comparison of the medical and traditional models of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single
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
- •>/= 4 or more periodontally involved teeth as defined by pocket depth of >/= 6mm.
- •>/= 14 teeth.
- •> 18 years of age.
- •Reside in the greater Boston area.
排除标准
- •Those patients requiring prophylactic antibiotic for dental treatment.
结局指标
主要结局
Tooth loss
Plaque accumulation
Suppuration
Bleeding on probing
Clinical attachment loss
Quality of life
次要结局
未报告次要终点
