Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection With Conventional Anesthesia (SLEEPER-ONE)

Comparison of Intraosseous Anesthesia Osteocentral With Electronic Assistance to Injection to a Conventional Anaesthesia by Infiltration on Temporary Molars

Anesthesia systems with electronic injection assistance for slow injection pressure-limiting drips (especially for intraosseous anaesthesia) are offered to limit pain. The European Academy of Pediatric Dentistry (EAPD) recommends them for their pen-like appearance which avoids the negative aspect of the classic syringe (Kühnisch 2017). A review systematic review of the literature (Smolarek et al 2019) including 20 randomized controlled trials conducted at children and adolescents showed a significant reduction in pain with the systems with electronic assistance compared to conventional anaesthesia performed with a syringe (-0.8: IC95% (-1.3, -0.3)). Only four of them (Tahmassebi et al 2009, Kandiah and Tahmassebi 2012, Patini et al 2018, Smail-Faugeron et al 2019) were at low risk of bias, and only two parallel group trials were of poor quality and included only children in temporary dentition in which anaesthesia, often problematic, was performed only in the maxilla (Allen et al 2002, Klein et al, 2005) without assessing the intensity of the pain felt.

(FPS-R).

The tested strategy, anesthesia system with electronic injection assistance (SleeperOne® 5 Dental Hi Tec), compared to a conventional metallic anaesthetic syringe currently considered as the standard for performing local anesthesia during oral treatments painful, meets the ISO 13485: 2016 standard.

Elements justifying that the particular surveillance modalities added by research do not involve negligible risks and constraints

Specific monitoring modalities added by research include :

• Explanation of the study to each eligible child and his or her legal guardians
• Gathering the informed consent of the child and his or her legal guardians
• The determination of comparative anesthesia systems (SleeperOne® 5 versus syringe metal)
• Data collection during the two care sessions (maximum 15 days apart)

It is a use of a product placed on the market whose conditions of use are in conformity with its destination and its current conditions of use (RIPH Category 2 application decree) There is no additional consultation or visit, nor any additional examination, in relation to the management in accordance with the recommendations of good practice of a child affected by a carious disease corresponding to the children included. On the other hand, the consultation will take a little longer due to the indicators to be collected and the data entry. These particular surveillance modalities added by research have only negligible constraints.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: sleeper one; Device: conventional technis

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France, 59000
    • Lille University Hospital
  • Nantes, France, 44000
    • Nantes University Hospital
  • Nice, France, 06000
    • Nice Hospital
  • Rennes, France, 35000
    • Rennes University Hospital
  • Toulouse, France, 31000
    • Toulouse University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 8 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Written consent of one of the two parents (legal guardians) and the child,
• Child and parents (legal guardians) speaking French,
• Child covered by his parents' social security coverage,
• Child aged 4-8 years in temporary stable denture,
• Child in good general health (ASAI or II),
• Child cooperating in care in the vigilant state (cooperation evaluated with a Venham score) 0, 1, 2).
• Child with two temporary molars of the same type, 1st or 2nd molars, controlateral (fractional mouth test) belonging to different quadrants of the the same arch (pair of teeth 54-64, 55-65, 74-84 or 75-85) and each requiring a single equivalent conservative treatment under anaesthesia (ICDAS 3 to 6 carious lesions on teeth) vital).

Exclusion Criteria:

They are declined at the scale of the subject and the tooth:

• Child having taken an analgesic treatment 24 hours before randomization,
• Child allergic to local anesthetics
• Child with at least one of the two temporary molars of the same pair (54-64, 55-65, 74-84 or 75-85) has inflammatory or infectious complications (symptomatology of irreversible pulpitis, clear radio image) and in front of this fact to make the object of a pulpectomy or avulsion :
• Molar presenting spontaneous pain outside of meals or continuous pain.
• Temporary molar whose radiographic examination reveals an enlargement of the space desmodontal, the presence of a radio-clear image at the furcation and/or the periapical regions, or even internal or external resorption.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sleeper one; Topical anesthesia: to be applied during 1 to 2 minutes on a previously dried mucous membrane (Lidocaine Gingival Gel, Septodont). Osteocentral anesthesia performed with the SleeperOne® 5 system (Dental Hi Tec) loaded with Articaine 1/200000 carpule.	Device: sleeper one; anesthesic injection with sleeper one device; Device: conventional technis; anesthesic injection with the conventional technic
Active Comparator: conventional technique; Topical anesthesia: to be applied during 1 to 2 minutes on a previously dried mucous membrane (Lidocaine Gingival Gel, Septodont). Anaesthesia using a conventional technique, i.e. a metal syringe loaded with Articaine 1/200000 carpule.	Device: sleeper one; anesthesic injection with sleeper one device; Device: conventional technis; anesthesic injection with the conventional technic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
patient pain	intensity of pain felt by the patient according to the face scale.	18 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (Actual): March 24, 2021
• Primary Completion (Actual): October 28, 2022
• Study Completion (Actual): November 24, 2022

Study Registration Dates

• First Submitted: November 10, 2020
• First Submitted That Met QC Criteria: November 10, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): March 20, 2023
• Last Update Submitted That Met QC Criteria: March 17, 2023
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: 20-AOI-06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No