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Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

NCT05531435 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-09-22

No results posted yet for this study

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.

Conditions

  • Dental Pain and Sensation Disorder
  • Dental Caries in Children

Interventions

DRUG

local anaesthetic injection

Local anesthetic injection of articaine 4% + adrenaline 1/100.000 (Septanest, Septodont, Saint Maur des Fossés, France) with 30G - 9 mm needle (DENTAL HI TEC, ZI de l'Appentière, Mazières-en-Mauges, France).

Sponsors & Collaborators

  • University of Pavia

    lead OTHER

Principal Investigators

  • Andrea Scribante, DDS, PhD · University of Pavia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
15 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05531435 on ClinicalTrials.gov