Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

Study Overview
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Brief Summary
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The purpose is to compare the efficacy of an intraosseous anaesthesia using a computerized system (QuickSleeper) to a conventional infiltration anesthesia. Our hypothesis is that anesthesia via QuickSleeper system can reduce pain during anesthesia and obtain a more rapid local anesthesia compared to the anesthesia via conventional technique by infiltration. Design: split-mouth design AND parallel-arm design

Detailed Description
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Local anesthesia is commonly used in oral health care and intra-mucosal infiltration anesthesia is most commonly used by practitioners. Anesthesia may cause children a great deal of anxiety because of the fear of the injection. The latter can be painful if the product is delivered too quickly in the mucosa. Recent developments in the techniques and anesthesia systems allow reducing pain during the injection. In particular, computerized systems (electronically assisted local anesthesia) allow a slow injection limiting pressure. Moreover, these systems look like a pen which prevents the negative impression of the image related to the syringe metal. The intraosseous electronically-assisted anesthesia could be an interesting alternative to conventional infiltration anesthesia by making the act less stressful but also less painful for the child.

Official Title
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Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia

Conditions
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Deep Caries, Molar Incisor Hypomineralisation

Intervention / Treatment
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* Procedure: intraosseous anaesthesia using a computerized system
* Procedure: conventional anasthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: split-mouth randomized controlled trial: patients with at least two first permanent molars requiring the same treatment with anesthesia parallel-arm radnomized controlled trial: patients with first permanent molar requiring treatment with anesthesia vital pulp patient did not take any pain medication 48 hours before randomization non-opposition of the child and two holders of parental participation in the study Treatments can be conservative treatment or endodontic treatment limited to pulpotomy. Exclusion Criteria: Patients with periodontal disease (periodontal pockets or tooth mobility) or radiological defects (necrosis, furcation or periapical radiolucency) Disabled or autistic patients Patients with cancer, heart disease or sickle cell anemia

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: conventional anasthesia<br>para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia | Procedure: conventional anasthesia<br>* para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia<br>|
| Experimental: intraosseous anaesthesia<br>intraosseous anaesthesia using a computerized system (Quicksleeper) 1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection  | Procedure: intraosseous anaesthesia using a computerized system<br>* 1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection <br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain reported by the patient according to the visual analogue scale (VAS) | Pain reported by the patient according to the visual analogue scale (VAS) will be evaluated at the end of the injection / infiltration. The assessment will concern the insertion of the needle and the injection / infiltration | up to 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| latency | latency (in minutes) evaluated by examining the sensitivity of the sulcus using a probe (an exam will be conducted every minute until the sulcus is insensitive to the probe) | up to 15 minutes | 
| need for additional anesthesia during the treatment |  | 1 hour | 
| pain felt during the treatment | need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS | 1 hour | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MIH of the first permanent molar