Randomized controlled clinical trial of long-term chemo-mechanical caries removal using PapacarieTM gel

Abstract

ObjectivesCompare the effectiveness of PapacarieTM gel for the chemo-mechanical removal of carious lesions on primary teeth to conventional caries removal with a low-speed bur with regard to execution time, clinical aspects and radiographic findings. Material and MethodsA randomized controlled clinical trial with a split-mouth design was carried out. The sample was composed of 20 children aged four to seven years, in whom 40 deciduous teeth were randomly divided into two groups: chemo-mechanical caries removal with PapacarieTM and removal of carious dentin with a low-speed bur. Each child underwent both procedures and served as his/her own control. Restorations were performed with glass ionomer cement. The time required to perform the procedure was also analyzed. The patients underwent longitudinal clinical and radiographic follow-up of the restorations. ResultsNo statistically significant difference between groups was found regarding the time required to perform the procedures and the radiographic follow up. Statistically significant differences between groups were found in the clinical evaluation at 6 and 18 months after treatment. ConclusionPapacarieTM is as effective as the traditional method for the removal of carious dentin on deciduous teeth, but offers the advantages of the preservation of sound dental tissue as well as the avoidance of sharp rotary instruments and local anesthesia.

Efficacy and Patient’s Acceptance of Alternative Methods for Caries Removal—A Systematic Review

“…Two [ 26 , 27 ] included studies followed a cross-over trial design, while eighteen [ 10 , 28 , 29 , 30 , 31 , 32 , 33 , 34 , 35 , 36 , 37 , 38 , 39 , 40 , 41 , 42 , 43 , 44 ] had a split-mouth design. One study [ 45 ] followed a two parallel-arms trial, five studies [ 46 , 47 , 48 , 49 , 50 ] provided one treatment per patient while five studies [ 15 , 51 , 52 , 53 , 54 ] had one or more treatment per patient.…”

Effects of Papacarie on children with dental caries in primary teeth: a systematic review and meta‐analysis

“…The trials’ publication date was from 2009 to 2016. Among these trials, three articles reported the same experiment; therefore, they were combined as Motta 2013–2014. Different regimens of the Papacarie method were identified in the included articles.…”

“…Among the included studies, five trials discussed the change in bacteria in the caries lesion, and two trials were excluded in the meta‐analysis for a lack of mean and SD data. In addition, 10 trials assessed the outcomes of pain perception before and after different caries removal methods; nevertheless, the scales used in these trials differ considerably. Only three trials used the Wong‐Baker‐Face Pain Scale (WBF) to evaluate pain perception and were remained eligible.…”

Effects of Papain-Based Gel Used For Caries Removal on Macrophages and Dental Pulp Cells

“…This papain-based gel is basically composed of a proteolytic enzyme that interacts with the partially degraded collagen present in the necrotic carious tissue (7). Some studies have addressed the effects of chemo-mechanical caries removal agents, in terms of clinical efficacy, acceptability, levels of pain, and success in the long term (3,(10)(11)(12)(13)(14). The effects of Papacárie Duo® on macrophage behaviour is not known, and its effects in cytotoxicity, viability and differentiation of undifferentiated dental pulp cells is scarce.…”