Treatment time, pain experience and acceptability of the technique for caries removal in primary teeth using the ART approach with or without Brix3000™ papain gel: a preliminary randomised controlled clinical trial.

PURPOSE: To compare the Atraumatic Restorative Treatment (ART) associated with Brix3000™ to ART considering treatment time, pain experienced, and acceptability to children. METHODS: This study was accepted in Research Ethics Committee in July 2019 (number 3469402). Healthy patients (n = 20) aged 3-9 years, with at least one primary molar with occlusal dentine caries without cusp involvement were randomly allocated to either the ART + Brix3000™ group or the ART-only group. The sample was characterised by sex, age, tooth location and caries experience. Time spent and pain experience scores were recorded at prophylaxis, caries removal and restoration. The pain experience (intense, moderate, or mild) was evaluated by the Face, Legs, Activity, Cry, Consolability-revised scale (FLACC-r). Acceptability was assessed by a five-point hedonic facial scale (dichotomised into 'like' and 'indifferent/dislike' bins) and by an open-question interview. Mann-Whitney, Chi-square, and Fisher's exact tests were applied to discern differences in time, pain/sample characterisation and acceptability, respectively. RESULTS: The ART + Brix3000™ group required 8.6 ± 3.1 min to remove caries tissue, whereas the ART group required only 4.8 ± 2.0 min (p = 0.03). The total time spent with treatments was 13.1 ± 4.0 min for ART + Brix3000™, and 9.8 ± 2.7 min for ART (p = 0.03). There was no difference in pain experience and acceptability found among the groups (p > 0.05). CONCLUSION: Although the ART + Brix3000™ technique demanded more treatment time than the ART alone, there were no differences in either pain experience or acceptability.