Pain during primary molar local anaesthesia with SleeperOne5 computerized device versus conventional syringe: A randomized, split-mouth, crossover, controlled trial

Background: Because of controversial results from clinical studies comparing different dental local anesthesia methods in children, the primary objective of this randomized, split-mouth, crossover, controlled trial was to compare pain intensity during local anaesthesia (LA) performed with a computer-controlled LA delivery system (C-CLADS) versus a conventional syringe (CONV). Secondary objectives included comparisons during dental treatment. Methods: Participants (4-8 years) with tooth pair requiring similar treatment were recruited from five French hospitals. The right primary molar, which was treated at the first visit, was randomly allocated to one of the anaesthesia groups (either intraosseous with C-CLADS or infiltration with CONV), whereas the contralateral molar (treated at the second visit) was assigned to the other group. Pain intensity and behaviour outcomes, assessed with the Faces Pain and Venham revised scales, respectively, were compared between groups using Proc mixed. Stratified analyses were performed on dentition and location. Results: Among 107 participants, the analysis revealed reduced pain perception during LA in the C-CLADS group compared with the CONV group (-0.72, 95% CI: -1.43, -0.006), but not during dental treatment. Stratified analyses showed that this effect was observed only in primary dentition (p = .006) and mandibular molars (p = .005). Behavioural issues were fewer in the C-CLADS group than in the CONV group (p = .05) only during injection. Conclusion: C-CLADS emerged as the preferable system in primary dentition.