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NCT05531435

Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

Completed NA Last updated 22 September 2022
What this trial tests

NA trial testing local anaesthetic injection in Dental Pain and Sensation Disorder in 30 participants. Completed in 21 September 2022.

Timeline
7 September 2022
Primary endpoint
21 September 2022
21 September 2022

Quick facts

Lead sponsorUniversity of Pavia
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment30
Start date7 September 2022
Primary completion21 September 2022
Estimated completion21 September 2022
Sites1 location across Italy

Drugs / interventions tested

Conditions studied

Sponsor

University of Pavia

Who can join

Adults 5 to 15, any sex, with Dental Pain and Sensation Disorder or Dental Caries in Children. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of local anaesthetic injection

Trials testing the same drug.

Other University of Pavia trials

Trials by the same sponsor.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05531435.

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