drugset / Trial / NCT05531435

Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

NCT05531435

Completed 30 enrolled University of Pavia
RandomizedParallel-groupDouble-blindTreatment

Summary

The aim of the present study is to assess if there are differences on perceived pain during local anesthesia performed with SleeperOne device or with a traditional syringe in pediatric patients. Patients responding to the inclusion criteria will be asked to participate to the study. After signing the informed consent, they will undergo local anesthesia procedure on first or second primary molars for the subsequent performing of dental filling. The split-mouth design will randomly allocate first or second primary molar from one quadrant to SleeperOne procedure, while the contralateral one will be subdued to local anesthesia with traditional syringe. After the procedure, patients will be asked to assess the perceived pain with a Visual Analogue Scale from a range 0-10. VAS scales will be used to assess sensations of "size" (related to the two instruments), bitter and vomit.

Timeline

Start
2022-09-07
Primary completion
2022-09-21
Completion
2022-09-21

Drugs

EvaluationDrugModalityDoseRoute
Background Articaine Other / unclassified 4 % Other
Background Epinephrine Other / unclassified Other