Effect of Different Liners on Pulpal Outcome after Partial Caries Removal: A Preliminary 12 Months Randomised Controlled Trial

Abstract

Aim: The aim of this double-blinded parallel randomised controlled trial was to compare the effect of different liners on 12-month pulp health outcomes after partial caries removal (PCR) with composite restorations in permanent molars. Methods: The study was registered at clinicaltrials.gov with registration No. NCT0328695 and conducted in the Department of Conservative dentistry and Endodontics, Post Graduate Institute of Dental Sciences Rohtak with no external financial support. One hundred and ninety-eight participants (116 males, 82 females and age 14–54 years) with vital permanent mature mandibular molars having deep caries involving two-thirds or more of dentin were randomised to calcium hydroxide (CH), resin-modified GIC (RMGIC) and no liner (DC) groups after PCR. After a follow-up time of 12 months, success was defined as positive response to pulp sensibility and absence of periapical alterations. Results: Categorical variables were compared using chi-square test. Two analytical approaches were used, such as intention-to-treat and per-protocol approach. Success rates in per-protocol approach were 96.8, 96.5, and 94.6% for CH, RMGIC and DC groups, respectively with no significant difference between 3 groups (p = 0.811). None of the baseline variables had any significant influence on the treatment success. Conclusion: Partial caries excavation has a high success rate to treat deep carious lesions in permanent teeth after 12 months of follow-up, indicating that the retention of carious dentin does not interfere with pulp vitality or restoration survival. Also, the success of the treatment is independent of the lining material used over the demineralized dentin.