drugset / Trial / NCT06992193

Effectiveness of Digital Anesthesia Versus Conventional Techniques in Reducing Pain and Anxiety in Children

NCT06992193

Completed 79 enrolled Ege University
RandomizedParallel-groupSingle-blindTreatment

Summary

This multicenter randomized controlled clinical trial was conducted to evaluate the effectiveness of digital anesthesia using a computer-controlled intraosseous system (SleeperOne 5®) compared to traditional local anesthesia techniques (infiltration and mandibular block) in paediatric dental patients. A total of 79 children aged 6-12 years were randomly assigned to one of three groups. Pain perception, anxiety levels, and behavioral responses were assessed using validated tools including the Wong-Baker FACES Pain Scale, the Modified Child Dental Anxiety Scale (MCDAS), and the FLACC behavioral scale. The study aimed to determine whether digital anesthesia could provide a less painful and less anxiety-inducing experience for children during dental treatment. Findings may support broader clinical adoption of computer-assisted anesthetic delivery in paediatric dentistry.

Timeline

Start
2025-01-08
Primary completion
2025-04-01
Completion
2025-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Benzocaine Small molecule Topical
Comparator Epinephrine Other / unclassified Other
Comparator Lidocaine Other / unclassified 1 ml Other

Indications

No indication recorded.