Clinical trial NCT02084433: Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
Official title: Comparison of Intraosseous Anaesthesia Using a Computerized System (QuickSleeper) to Conventional Anesthesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deep Caries
Molar Incisor Hypomineralisation
Keywords: MIH of the first permanent molar
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2014-03-12
Enrollment: 158
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pain reported by the patient according to the visual analogue scale (VAS)
timeFrame: up to 10 minutes
Secondary outcomes:
measure: latency
timeFrame: up to 15 minutes
measure: need for additional anesthesia during the treatment
timeFrame: 1 hour
measure: pain felt during the treatment
timeFrame: 1 hour
Other outcomes:
Locations:
city: Paris
country: France
facility: Hôpital Bretonneau
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Frédéric Courson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Evaluation of intraosseous computerized injection system (QuickSleeper) vs conventional infiltration anaesthesia in paediatric oral health care: A multicentre, single-blind, combined split-mouth and parallel-arm randomized controlled trial. Int J Paediatr Dent. 2019 Sep;29(5):573-584. doi: 10.1111/ipd.12494. Epub 2019 Apr 8.
citation: Smail-Faugeron V, Muller-Bolla M, Sixou JL, Courson F. Split-mouth and parallel-arm trials to compare pain with intraosseous anaesthesia delivered by the computerised Quicksleeper system and conventional infiltration anaesthesia in paediatric oral healthcare: protocol for a randomised controlled trial. BMJ Open. 2015 Jul 10;5(7):e007724. doi: 10.1136/bmjopen-2015-007724.