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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Molar Incisor Hypomineralisation; Deep Caries

Treatments: Procedure: conventional anasthesia; Procedure: intraosseous anaesthesia using a computerized system

Study type: Interventional

Funder types: Other

Identifiers

NCT02084433

75018

Details and patient eligibility

About

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

Full description

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.

Enrollment: 158 patients

Sex: All

Ages: 7 to 15 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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158 participants in 2 patient groups

conventional anasthesia

Active Comparator group

Description:

para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia

Treatment:

Procedure: conventional anasthesia

intraosseous anaesthesia

Experimental group

Description:

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 "

Treatment:

Procedure: intraosseous anaesthesia using a computerized system