Sealing of cavitated occlusal carious lesions in the dentine of deciduous molars: a two-year randomised controlled clinical trial

Objectives This two-arm, parallel-group, tooth-randomised, controlled noninferiority clinical trial aimed to compare survival rates between the sealing and restoring of cavitated occlusal carious lesions in dentine [International Caries Detection and Assessment System (ICDAS) 5] of deciduous molars using resin-modified glass-ionomer cement (RMGIC) and to assess caries progression radiographically. Materials and methods A total of 68 molars with ICDAS 5 occlusal lesions were randomly allocated into two groups, a sealing group (n = 31), in which RMGIC was placed directly over the carious lesion, and a restoration group (n = 37), in which a restoration with the same material was placed after selective caries removal. During the baseline and follow-up visits, dental caries was registered and caries activity was assessed according to a visuotactile criterion. At baseline, patient caries status (dmf-t) and cavity depth and extent (mesiodistal and buccolingual) were measured before RMGIC placement. An independent and blinded examiner evaluated the treated teeth using the USPHS criteria after one and two years. Standardised interproximal radiographs were taken for caries progression assessments. Results During the follow-up period, no lesion progression was observed radiographically. After one year (n = 60; 27 sealed and 33 restored) and two years (n = 48; 23 sealed and 25 restored) of follow-up, the treatment success rates were 78.8% and 76.0% in the restoration group and 59.3% and 47.8% in the sealing group, respectively. Multivariate Cox regression showed that lesions smaller than 2 mm in the mesiodistal extent were less prone to fail after one year (p = 0.03). However, survival curves (log-rank test) were statistically significantly different only after two years (p < 0.001). Conclusions Sealing ICDAS 5 occlusal lesions of deciduous molars using RMGIC achieved lower survival rates than restorations. Both sealing and restoration effectively arrested caries progression for two years. Clinical relevance Sealing dentine carious lesions can be effective for treating lesions involving the inner and outer half of the dentine. Ultraconservative treatments can arrest carious lesions presenting obvious cavitation in primary molars. Trial Registration: ReBEC Register no. RBR-225n35.