Local Anesthesia With Computerized Device for Restorative Procedures in Pediatric Patients

NCT05531435 | Completed

• 1 other identifier: 2022-SLEEPERONE
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

dental anesthesia

Outcome Measures

Primary Outcomes (1)

• Pain measure

  Self-reported pain by the patient immediately after local anesthesia infiltration using a VAS (visual analogue scale), containing a combination of Numeric Rating Scale (0-10, where 0 means no pain, 10 - worst possible pain) and Wong-Baker Faces Pain Scale, including pictures of facial expressions with correlating numbers of 0-10 (0 being 'no hurt' and 10 being 'hurts worst'). The combination allows children to pick a facial expression, that corresponds with their pain and see a number that matches it.

  Baseline

Secondary Outcomes (3)

• Size sensation

  Baseline

• Bitter sensation

  Baseline

• Vomit sensation

  Baseline

Study Arms (2)

SleeperOne

EXPERIMENTAL

SleeperOne S4 (Revello S.p.A., Verona, Italy) appliance will be used for the administration of local anesthetic.

Drug: local anaesthetic injection

Traditional anesthesia

ACTIVE COMPARATOR

Local anesthesia will be performed with a traditional syringe (0480-1, ASA Dental, Massarosa, LU, Italy).

Drug: local anaesthetic injection

Interventions

local anaesthetic injection DRUG

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).

SleeperOne; Traditional anesthesia

Eligibility Criteria

• Age: 5 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• gingivitis
• dental abscesses, facial traumas/injuries
• drugs (NSAIDS, paracetamol, antibiotics)

Sponsors & Collaborators

• University of Pavia: lead

Study Sites (1)

Unit of Orthodontics and Pediatric Dentistry - Section of Dentistry - Department of Clinical, Surgical, Diagnostic and Pediatrics - University of Pavia

Pavia, Lombardy, 27100, Italy

Location

Related Publications (1)

• Palm AM, Kirkegaard U, Poulsen S. The wand versus traditional injection for mandibular nerve block in children and adolescents: perceived pain and time of onset. Pediatr Dent. 2004 Nov-Dec;26(6):481-4.

  PMID: 15646908 BACKGROUND

MeSH Terms

Conditions

Toothache; Sensation Disorders

Interventions

Anesthesia, Local

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Facial Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia

Study Officials

• Andrea Scribante, DDS, PhD

  University of Pavia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Principal Investigator

Model Details: Split-mouth design

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 8, 2022
• Study Start: September 7, 2022
• Primary Completion: September 21, 2022
• Study Completion: September 21, 2022
• Last Updated: September 22, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)