Trial reportBMC oral health2026
Calcium silicate liner versus no liner in selective caries removal: a one-year randomized clinical trial.
Trial report in BMC oral health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04743219 (Selective Removal Technique With or Without the Use of a Bioactive Material for the Management of Deep Caries Lesions in Permanent Posterior Teeth With Close Apex. A Randomized Clinical Trial.), which is not on this map. Not yet cited in PubMed.
What it found
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The trial behind it
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Selective Removal Technique With or Without the Use of a Bioactive Material for the Management of Deep Caries Lesions in Permanent Posterior Teeth With Close Apex. A Randomized Clinical Trial.
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Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
BACKGROUND/
objectivesSelective removal to soft dentine (SRSD) is recommended to minimize pulp exposure in deep carious lesions. The use of calcium silicate-based liners has been advocated to enhance pulp protection; however, their true clinical benefit remains controversial. This study aimed to compare the clinical and radiographic success of the SRSD technique with and without the use of a bioactive liner in permanent posterior teeth with closed apex after 12 months.
methodsA double-blind, randomized controlled trial was conducted in patients aged 15–62 years with deep carious lesions in posterior permanent teeth with normal or reversible pulpitis. Teeth were randomly assigned to two groups: application of a hydraulic calcium silicate-based cement (Biodentine™) or no liner (direct adhesive procedure). All cavity preparations and restorations were performed under rubber dam isolation. The primary outcome was treatment success (maintained or lost vitality at 12 months), with the tooth as the unit of analysis. Success was defined as absence of symptoms, normal pulp sensibility response, no clinical signs of inflammation or infection, and absence of periapical pathology on radiographs. Continuous and categorical variables were compared using Wilcoxon and Fisher’s exact tests, respectively, with FDR-adjusted p-values (α = 0.05).
resultsA total of 45 teeth in 32 patients were treated. At the 12-month follow-up, 33 teeth were available for evaluation, corresponding to a drop-out rate of 26.7% at the restoration level. At the patient level, the overall drop-out rate was 37.5%. Both groups achieved 100% success rates with no statistically significant differences. All teeth maintained normal pulp responses, were asymptomatic, and showed healthy periapical structures. Restoration quality was acceptable according to FDI criteria, with no failures or adverse events recorded.
conclusionsAfter 12 months, the use of a calcium silicate-based liner did not significantly impact the clinical or radiographic success of the SRSD technique in deep caries lesions. A direct adhesive approach without a liner may be a reliable, simpler, and cost-effective alternative for maintaining pulp vitality.
trial registrationThe study was approved by the University Ethics Committee (protocol code 0212202023220) and registered at ClinicalTrials.gov (Identifier: NCT04743219; date of registration: 01/02/2021).
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