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

Not Applicable

Completed

• Conditions: Deep Caries; Molar Incisor Hypomineralisation
• Interventions: Procedure: conventional anasthesia; Procedure: intraosseous anaesthesia using a computerized system

• Registration Number: NCT02084433
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2014-03-06
• Study First Submitted QC: 2014-03-07
• Study First Posted: 2014-03-12
• Study Start: 2015-01
• Status Verified: 2017-02
• Primary Completion: 2017-02
• Study Completion: 2017-02
• Last Update Submitted: 2017-02-22
• Last Update Posted: 2017-02-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional anasthesia	conventional anasthesia	para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia
intraosseous anaesthesia	intraosseous anaesthesia using a computerized system	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 "

Primary Outcome Measures

Name	Time	Method
Pain reported by the patient according to the visual analogue scale (VAS)	up to 10 minutes	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

Secondary Outcome Measures

Name	Time	Method
need for additional anesthesia during the treatment	1 hour
pain felt during the treatment	1 hour	need for additional anesthesia during the treatment; pain felt during the treatment evaluated at the end of treatment according to the VAS
latency	up to 15 minutes	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)

Trial Locations

Locations (1)

Hôpital Bretonneau; 🇫🇷 Paris, France