Changes in Caries Risk in a Practice-Based Randomized Controlled Trial

Abstract

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).

Keywords: Caries Management by Risk Assessment (CAMBRA); Practice-Based Research Network (PBRN); caries prevention; caries risk assessment; dental caries; disease indicators.

Figure 1.

Consolidated Standards of Reporting Trials (CONSORT) flowchart with patients followed from baseline and at each follow-up visit, by group status. PBRN, Practice-Based Research Network.

Figure 2.

Change in caries risk levels and development of new disease indicators. (A) Among patients classified as high caries risk at baseline, percentage of patients staying at high risk over time for intervention and control group. (B) Among patients classified as low caries risk at baseline, percentage of patients with increased risk level over time for intervention and control group. (C) Patients with initial high risk, percentage developing any of the 4 clinical outcomes/disease indicators (cavities on radiographic into dentin, proximal enamel lesions on radiographs, active white spot lesions on smooth surfaces, restorations within prior year). *Percentages statistically significant different (cluster-adjusted P < 0.05).