title: 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.
abstract: BACKGROUND
  Local anaesthesia is commonly used in paediatric oral healthcare. Infiltration anaesthesia is the most frequently used, but recent developments in anaesthesia techniques have introduced an alternative: intraosseous anaesthesia. We propose to perform a split-mouth and parallel-arm multicentre randomised controlled trial (RCT) comparing the pain caused by the insertion of the needle for the injection of conventional infiltration anaesthesia, and intraosseous anaesthesia by the computerised QuickSleeper system, in children and adolescents.
  
  
  METHODS
  Inclusion criteria are patients 7-15 years old with at least 2 first permanent molars belonging to the same dental arch (for the split-mouth RCT) or with a first permanent molar (for the parallel-arm RCT) requiring conservative or endodontic treatment limited to pulpotomy. The setting of this study is the Department of Paediatric Dentistry at 3 University dental hospitals in France. The primary outcome measure will be pain reported by the patient on a visual analogue scale concerning the insertion of the needle and the injection/infiltration. Secondary outcomes are latency, need for additional anaesthesia during the treatment and pain felt during the treatment. We will use a computer-generated permuted-block randomisation sequence for allocation to anaesthesia groups. The random sequences will be stratified by centre (and by dental arch for the parallel-arm RCT). Only participants will be blinded to group assignment. Data will be analysed by the intent-to-treat principle. In all, 160 patients will be included (30 in the split-mouth RCT, 130 in the parallel-arm RCT).
  
  
  BACKGROUND
  This protocol has been approved by the French ethics committee for the protection of people (Comité de Protection des Personnes, Ile de France I) and will be conducted in full accordance with accepted ethical principles. Findings will be reported in scientific publications and at research conferences, and in project summary papers for participants.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT02084433.
authors.affiliation: Institut National de la Santé et de la Recherche Médicale, U1138, Equipe 22, Centre de Recherche des Cordeliers, Paris, France Service d'Odontologie, Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris, France Faculté de Chirurgie Dentaire, Unité de Recherches Biomatériaux Innovants et Interface EA4462, Université Paris Descartes-Sorbonne Paris Cité, Montrouge, France.
authors.forename: Violaine
authors.initials: V
authors.lastname: Smaïl-Faugeron
authors.affiliation: Faculté de Chirurgie Dentaire, Unité de Recherches Biomatériaux Innovants et Interface EA4462, Université Paris Descartes-Sorbonne Paris Cité, Montrouge, France Service d'Odontologie, Faculté de Chirurgie Dentaire, Université de Nice-Sophia Antipolis, Nice, France.
authors.forename: Michèle
authors.initials: M
authors.lastname: Muller-Bolla
authors.affiliation: Université Européenne de Bretagne, Université de Rennes 1 and Centre Hospitalier Universitaire de Rennes, Rennes, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Sixou
authors.affiliation: Service d'Odontologie, Assistance Publique-Hôpitaux de Paris, Hôpital Bretonneau, Paris, France Faculté de Chirurgie Dentaire, Unité de Recherches Biomatériaux Innovants et Interface EA4462, Université Paris Descartes-Sorbonne Paris Cité, Montrouge, France.
authors.forename: Frédéric
authors.initials: F
authors.lastname: Courson
mesh_terms: D000293:Adolescent; D000766:Anesthesia, Dental / Q000295:instrumentation* / Q000379:methods; D000772:Anesthesia, Local / Q000295:instrumentation*; D002648:Child; D003625:Data Collection; D006801:Humans; D008963:Molar; D009339:Needles; D010146:Pain / Q000517:prevention & control*; D010147:Pain Measurement; D018579:Patient Selection; D018401:Sample Size; D014076:Tooth Diseases / Q000601:surgery*; D016896:Treatment Outcome
keywords: ORAL MEDICINE; PUBLIC HEALTH