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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

18-75 Years
5 to 15 Years
All
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?

Yes

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

No

Exclusion Criteria

- gingivitis

- dental abscesses, facial traumas/injuries

- drugs (NSAIDS, paracetamol, antibiotics)

Locations

Location

Status