NCT02084433.

Trial name or title	Comparison of intraosseous anaesthesia using a computerized system (QuickSleeper) to conventional anaesthesia (QUICK)
Methods	Study design: randomised controlled trial, parallel design (and split‐mouth design) Location: France
Participants	Inclusion criteria: for split‐mouth design: patients with at least 2 first permanent molars requiring the same treatment with anaesthesia; for parallel‐arm design: patients with first permanent molar requiring treatment with anaesthesia; vital pulp; patient did not take any pain medication 48 hours before randomisation; non‐opposition of the child and 2 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 anaemia Estimated number of participants to be enrolled: 160 Elligible age range: 7 to 15 years old
Interventions	Group 1 (control): conventional LA Group 2: intraosseous LA
Outcomes	Pain reported by the patient according to VAS at the end of the injection/infiltration 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) Need for additional anaesthesia during the treatment using VAS Pain felt during the treatment using VAS
Starting date	January 2015
Contact information	Frédéric Courson (frederic.courson@parisdescartes.fr) Violaine Smaïl‐Faugeron (violaine.smail‐faugeron@parisdescartes.fr)
Notes