drugset / Trial / NCT05443009

Self-Reported Pain in Children Submitted to Single Infiltration of Articaine During Primary Molar Extraction

NCT05443009 ↗

Phase 4 Completed 76 enrolled Universidade Federal de Santa Catarina
RandomizedParallel-groupSingle-blindTreatment

Summary

The aim of this study is to analyze the effectiveness of articaine in controlling self-reported pain compared with conventional lidocaine anesthesia in children requiring extraction of deciduous maxillary molars. Only one extraction will be performed on each child. At least two consultations will be necessary to carry out the present controlled, randomized, and blinded study. All participants will be treated by the same dentist. Self-reported pain will be assessed using the Visual Analogue Scale.

Timeline

Start
2022-06-30
Primary completion
2024-07-04
Completion
2024-11-21

Outcome

Missed primary endpoint

paper The upper limit of the 95% CI (3.90 cm) exceeded the noninferiority margin, precluding confirmation of noninferiority (P = .919). PMID 40932429 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Articaine Other / unclassified 4 % —
Comparator Lidocaine Other / unclassified 2 % —

Indications