Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients
Sponsored by University of Pavia
About this trial
Last updated 3 years ago
Study ID
2022-SLEEPERONE
Status
Completed
Type
Interventional
Phase
N/A
Placebo
No
Accepting
5 to 15 Years
All
Trial Timing
Ended 3 years ago
What is this trial about?
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.
What are the participation requirements?
Inclusion Criteria
- presence of dental caries requiring filling with local anesthesia on first or second primary molar
- presence of dental caries requiring filling with local anesthesia on the contralateral primary molar
Exclusion Criteria
- gingivitis
- dental abscesses, facial traumas/injuries
- drugs (NSAIDS, paracetamol, antibiotics)