Rechmann P, Chaffee B W, Rechmann B M T, Featherstone J D B
1 Department of Preventive and Restorative Dental Sciences, School of Dentistry, University of California at San Francisco, San Francisco, CA, USA.
Adv Dent Res. 2018 Feb;29(1):15-23. doi: 10.1177/0022034517737022.
To demonstrate that Caries Management by Risk Assessment (CAMBRA) can be successfully implemented in dental practice, 30 dentists were recruited to perform a 2-y CAMBRA trial. Twenty-one dentists (18 private practices, 3 community clinics) participated in a randomized, controlled, parallel-arm, double-blind clinical trial with individual-level assignment of 460 participants to standard of care (control) versus active CAMBRA treatment (intervention). Control or active antimicrobial and remineralizing agents were dispensed at baseline and 6-, 12-, 18-, and 24-mo recall visits according to risk level and assigned treatment arm. Primary outcome measure was dentist-determined caries risk level at recall. Among initially high-risk participants, secondary outcomes were recorded disease indicators. Generalized estimating equations were used to fit log-linear models for each outcome while accounting for repeated measurements. At 24 mo, follow-up rates were 34.3% for high-risk participants (32.1% intervention, 37.1% control) and 44.2% for low-risk participants (38.7% intervention, 49.5% control). Among 242 participants classified as high caries risk at baseline (137 intervention, 105 control), a lower percentage of participants remained at high risk in the intervention group (statistically significant at all time points). At 24 mo, 25% in the intervention group and 54% in the control group remained at high risk ( P = 0.003). Among 192 participants initially classified as low risk (93 intervention, 99 control), most participants remained at low risk. At 24 mo, 89% in the intervention group and 71% in the control group were low caries risk ( P = 0.18). The percentage of initially high-risk participants with recorded disease indicators decreased over time in both intervention and control groups, being always lower for the intervention group (statistically significant at the 12- and 18-mo time point). In this practice-based clinical trial, a significantly greater percentage of high-caries-risk participants were classified at a lower risk level after CAMBRA preventive therapies were provided. Most participants initially assessed at low caries risk stayed at low risk (ClinicalTrials.gov NCT01176396).
为证明通过风险评估进行龋病管理（CAMBRA）能够在牙科实践中成功实施，招募了30名牙医开展一项为期2年的CAMBRA试验。21名牙医（18家私人诊所、3家社区诊所）参与了一项随机、对照、平行组、双盲临床试验，将460名参与者按个体水平分配至标准治疗（对照组）与积极的CAMBRA治疗（干预组）。根据风险水平和分配的治疗组，在基线以及6个月、12个月、18个月和24个月的复诊时发放对照或活性抗菌及再矿化剂。主要结局指标是复诊时牙医确定的龋病风险水平。在最初为高风险的参与者中，次要结局是记录的疾病指标。使用广义估计方程为每个结局拟合对数线性模型，同时考虑重复测量。在24个月时，高风险参与者的随访率为34.3%（干预组32.1%，对照组37.1%），低风险参与者的随访率为44.2%（干预组38.7%，对照组49.5%）。在基线时被分类为高龋病风险的242名参与者中（137名干预组，105名对照组），干预组中处于高风险的参与者比例较低（在所有时间点均具有统计学意义）。在24个月时，干预组中有25%的参与者仍处于高风险，而对照组中这一比例为54%（P = 0.003）。在最初被分类为低风险的192名参与者中（93名干预组，99名对照组），大多数参与者仍处于低风险。在24个月时，干预组中有89%的参与者为低龋病风险，对照组中这一比例为71%（P = 0.18）。在干预组和对照组中，最初高风险且有记录疾病指标的参与者比例均随时间下降，且干预组始终较低（在12个月和18个月时间点具有统计学意义）。在这项基于实践的临床试验中，在提供CAMBRA预防性治疗后，高龋病风险参与者中被分类为较低风险水平的比例显著更高。大多数最初评估为低龋病风险的参与者仍处于低风险（ClinicalTrials.gov NCT01176396）。
