Sealing Proximal Non- and Micro-Cavitated Carious Lesions Using a One-Session Separator Technique: A 2-Year Randomised Clinical Study

The presence of initial caries accounts for the majority of approximal carious lesions in many countries. The aim of this clustered, split-mouth, randomised, controlled clinical trial was to use a metal separator to widen the approximal space in a one-visit session before sealing and to evaluate patient acceptance, together with the efficacy of the proximal sealing in arresting incipient carious lesions after 2 years. A total of 48 patients with a mean age of 41.9 years were selected. They had at least one pair of proximal initial carious lesions, including the distal surface of the canines to the mesial surface of the third molars (bite-wing score D1–D3). The patient’s caries risk at baseline was analyzed using a Cariogram. All surfaces were examined for mutans streptococci (ms) counts. The separator technique made it possible to diagnose whether or not a microcavity was present. After 2 years, 212 surfaces in 45 subjects were examined using the same as baseline standardized digital follow-up radiographs. Two analyses were performed, one sensitive, where a progression or a regression was assessed if one of the examiners made one of those diagnoses, and one conservative, where unchanged. For both analyses, the sealed test surfaces showed a significantly higher regression (67 and 29%) compared to the control group (13 and 2%) p < 0.0001. It did not appear that the baseline variables, such as the caries risk, surface diagnoses, or ms counts, influenced the caries outcome. In the test group, there was no difference in caries progression if there was a microcavity or not. The separation treatment was well accepted by the patients. The method of separation for diagnosis and sealing treatment in a single session appears to be a clinically applicable method for the control of proximal carious lesions.