Selective vs stepwise removal of deep carious lesions in primary molars: 12-Months results of a randomized controlled pilot trial

Abstract

ObjectivesFor deep carious lesions, selective or stepwise carious tissue removal (SE, SW) seem advantageous compared with non-selective removal. For primary molars, there is insufficient evidence comparing SE against SW. This randomized pilot trial compared SE and SW over 12 months. MethodsA two-arm superiority trial was conducted comparing SE and SW in primary molars with deep lesions but without pulpal symptoms. We recruited 74 children (one molar/child) aged 3–9 years. In both groups, peripheral carious tissue removal was performed at T1 to hard dentin. In proximity to the pulp, leathery dentin was left followed by an adhesive compomer restoration. Blinded re-examination was performed after six months (T2). Molars allocated to SW were re-entered, removal to firm dentin carried out pulpo-proximally, and again restored. After another 6 months, all molars were re-examined (T3). Our primary outcome was success, defined as no restorative/endodontic complications (including pulp exposure) leading to reinterventions. Secondary outcomes included total treatment and opportunity costs. Patients’, dentists’ and parents’ subjective assessments were recorded. This trial was registered (ClinicalTrials.gov/NCT02232828). ResultsAfter 12 months a total of 72 children (36 SE, 36 SW) were analyzed. Three failures occurred (2 exposures in SW, 1 pulpal complication leading to extraction in SE) (p > 0.05). The subjective evaluation by patients, parents or dentists did not differ significantly. Combined treatment and opportunity costs were significantly higher in SW (mean;SD: 186;61 Euro) than SE (100;59) (p < 0.001). ConclusionsThe significantly increased costs for performing SW instead of SE in deep carious lesions in primary molars may not be justified. Clinical significanceFor primary molars with deep lesions, but vital pulps, SE was less costly at similar efficacy compared with SW. Dentists’ decision-making should consider this alongside further clinical aspects.