Blinkhorn Andy
Population Oral Health, Faculty of Dentistry, University of Sydney, Sydney, Australia.
Evid Based Dent. 2010;11(2):41. doi: 10.1038/sj.ebd.6400716.
A patient-randomised controlled trial (RCT) and a cluster RCT of the same intervention were conducted independently of each other.
The evidence-based intervention (a powered toothbrush and behavioural advice on timing, method and duration of toothbrushing) was framed to target oral hygiene self-efficacy (Social Cognitive Theory) and action plans (Implementation Intention Theory) to influence oral hygiene behaviour and therefore clinical outcomes. The content and the delivery of the intervention were standardised as a series of steps-altogether taking approximately 5 min. The control groups received routine care, even if that included oral hygiene advice.
The primary outcome measures were behavioural (timing, duration and method of toothbrushing) matching the advice given in the intervention. Secondary outcomes were cognitive measures of self-efficacy and planning, and clinical measures of plaque and gingival bleeding.
The study included 87 dental practices and 778 patients (patient RCT, 37 dentists and 300 patients; cluster RCT, 50 dentists and 478 patients). Controlled for baseline differences, pooled results showed that trial participants who experienced the intervention had better behavioural (timing, duration, method), cognitive (confidence, planning), and clinical (plaque, gingival bleeding) outcomes. Clinical outcomes were only significantly better in the cluster RCT, however.
A simple, theory-based intervention delivered within the constraints of a primary care environment was more effective than routine care in influencing patients' oral hygiene cognitions, behaviour and health. As clinical outcomes were significantly better only in the cluster RCT, the impact of trial design on results needs to be further explored.
开展了一项患者随机对照试验（RCT）以及针对相同干预措施的整群随机对照试验，二者相互独立进行。
循证干预措施（电动牙刷以及关于刷牙时间、方法和时长的行为建议）旨在针对口腔卫生自我效能（社会认知理论）和行动计划（实施意图理论），以影响口腔卫生行为进而改善临床效果。干预措施的内容和实施方式被标准化为一系列步骤，总共耗时约5分钟。对照组接受常规护理，即便其中包含口腔卫生建议。
主要结局指标是与干预措施中给出的建议相匹配的行为指标（刷牙时间、时长和方法）。次要结局指标包括自我效能和计划的认知指标，以及牙菌斑和牙龈出血的临床指标。
该研究纳入了87家牙科诊所和778名患者（患者随机对照试验，37名牙医和300名患者；整群随机对照试验，50名牙医和478名患者）。在控制了基线差异后，汇总结果显示，接受干预的试验参与者在行为（时间、时长、方法）、认知（信心、计划）和临床（牙菌斑、牙龈出血）方面取得了更好的结果。不过，临床结果仅在整群随机对照试验中显著更好。
在初级保健环境的限制条件下实施的一种基于理论的简单干预措施，在影响患者的口腔卫生认知、行为和健康方面比常规护理更有效。由于临床结果仅在整群随机对照试验中显著更好，试验设计对结果的影响有待进一步探究。
