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

Deep Caries Clinical Trial

— QUICK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02084433
• Other study ID #: 75018
• Status: Completed
• Phase: N/A
• First received: March 6, 2014
• Last updated: February 22, 2017
• Start date: January 2015
• Est. completion date: February 2017

Study information

• Verified date: February 2017
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Deep Caries
• Dental Enamel Hypoplasia
• Molar Incisor Hypomineralisation

Intervention

Procedure:
• intraosseous anaesthesia using a computerized system
"1 / Anesthesia of periosteum (Articaine 1/100000) 2 / penetration of the needle rotated to the apex 3 / osteocentral injection "
• conventional anasthesia
para-apical maxillary and locoregional mandibular (Articaine 1/100000) anaesthesia

Locations

Country	Name	City	State
France	Hôpital Bretonneau	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	need for additional anesthesia during the treatment		1 hour
Secondary	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