Changes in Caries Risk in a Practice-Based Randomized Controlled Trial.
Changes in Caries Risk in a Practice-Based Randomized Controlled Trial.
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DOI：
10.1177/0022034517737022
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发表时间：
2018-02-01
影响因子：
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通讯作者：
Featherstone, J D B
中科院分区：
文献类型：
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作者：
Rechmann, P;Chaffee, B W;Featherstone, J D B
为了证明龋齿风险评估管理（CAMBRA）可以在牙科实践中成功实施，招募了30名牙医进行为期2年的CAMBRA试验。21名牙医（18家私人诊所，3家社区诊所）参加了一项随机、对照、平行组、双盲临床试验，其中460名参与者被分配到标准治疗（对照）与活性CAMBRA治疗（干预）。根据风险水平和指定的治疗组，在基线和6个月、12个月、18个月和24个月的回忆访视时分配对照或活性抗菌剂和再矿化剂。主要结局指标是牙医在回忆时确定的龋齿风险水平。在最初的高风险参与者中，次要结局是记录的疾病指标。广义估计方程被用来拟合对数线性模型的每一个结果，同时占重复测量。在24个月时，高风险参与者的随访率为34.3%（32.1%干预，37.1%对照），低风险参与者为44.2%（38.7%干预，49.5%对照）。在基线时被归类为高龋齿风险的242名参与者中（137名干预组，105名对照组），干预组中仍处于高风险的参与者比例较低（在所有时间点都具有统计学意义）。在24个月时，干预组中有25%的患者和对照组中有54%的患者仍处于高风险状态（P = 0.003）。在最初被归类为低风险的192名参与者中（93名干预，99名对照），大多数参与者仍然处于低风险状态。在24个月时，干预组中89%和对照组中71%的患龋风险较低（P = 0.18）。在干预组和对照组中，记录有疾病指标的初始高风险参与者的百分比随着时间的推移而下降，干预组始终较低（在12个月和18个月时间点具有统计学显著性）。在这项基于实践的临床试验中，在提供CAMBRA预防性治疗后，高龋齿风险参与者的比例显着增加，被归类为较低的风险水平。大多数最初评估为低龋齿风险的参与者保持在低风险（ClinicalTrials.gov NCT 01176396）。
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).