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

Abstract

Objectives: For 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.

Methods: A 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).

Results: After 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).

Conclusions: The significantly increased costs for performing SW instead of SE in deep carious lesions in primary molars may not be justified.

Clinical significance: For 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.

Keywords: Caries; Costs; Dentin; One-step removal; Partial removal; Two-step removal.