Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial

Abstract

BackgroundFor treating deep caries lesions, selective or stepwise (one- and two-step) incomplete excavation seems advantageous compared with complete caries removal. However, current evidence regarding the success, as defined by not requiring any retreatments, or survival of teeth after different excavations is insufficient for definitive recommendation, especially when treating deciduous teeth. Moreover, restoration integrity has not been comparatively analyzed longitudinally, and neither patients’, dentists’ or parents’ preferences nor the clinical long-term costs emanating from both initial and retreatments have been reported yet.Methods/DesignThe planned study is a prospective multicenter, two-arm parallel group, randomized controlled clinical trial comparing selective and stepwise excavation in deciduous molars with deep, active caries lesions without pulpal symptoms. We will recruit 300 children aged between three and nine-years-old with a minimum of one such molar. Patients participating in another study, or those with systemic diseases, disabilities or known allergies to used materials as well patients with teeth expected to exfoliate within the next 18 months will be excluded. After inclusion, sequence generation will be performed. Initial treatment will follow dental routine. During excavation, leathery, moist and reasonably soft dentin will be left in proximity to the pulp followed by adhesive restoration of the cavity. Afterwards, patients’, dentists’ and parents’ subjective assessment of the treatment will be recorded using visual analogue or Likert scales. Re-examination will be performed after six months, and only then teeth will be allocated to one of the two interventions. Selectively excavated teeth will not be treated further, whilst for stepwise caries removal, a second excavation will be performed until only hard dentin remains. Clinical re-evaluations will be performed after 12, 24 and 36 months. Restorations will be reassessed using modified Ryge criteria. Objectively or subjectively required retreatments will determine success and survival. Retreatments will be evaluated both subjectively and regarding generated costs.DiscussionBased on the results of the trial, decision-making for treating deep caries lesions in deciduous molars based on multiple criteria should be feasible.Trial registrationClinicaltrials.gov identifier: NCT02232828 (registered on 29 November 2014).

Clinical performance of restorative materials in primary molar teeth

“…Modified Ryge criteria from USPHS guidelines had been used to evaluate the restorations in this study. These criteria had been used in the majority of clinical research before and reliable criteria to be used in evaluating restorations [15,16,17]. However, the criteria did not have any radiograph examination.…”

Current trends in the conservative treatment of deep-caries lesion with risk of pulp exposure

“…35 However, as this is a recent technique, its disadvantage is that it requires more longitudinal studies, even though it already shows positive results in research performed with permanent and primary teeth. 12, [36][37][38][39][40]…”

Strategies for control and treatment of carious lesions in deciduous molars: a review of the literature

“…Thus, for treating deep carious lesions, selective or gradual removal of decayed tissue, done in one and two clinical sessions respectively, seems to have an advantage over the total removal of decayed tissue 44 . However, since several studies have found residual lesions arrested using clinical and microbiological criteria, after adequate sealing of the cavity, the need for the reopening of the tooth has been increasingly questioned 20 .…”