Evaluating dental anxiety in children having GA/ inhalation sedation

  • Research type

    Research Study

  • Full title

    The short and long-term effects of nitrous oxide/oxygen sedation as compared with general anaesthesia on children’s future level of dental anxiety and acceptance of dental treatment

  • IRAS ID

    274862

  • Contact name

    Richard Balmer

  • Contact email

    R.C.Balmer@leeds.ac.uk

  • Sponsor organisation

    University of Leeds

  • Clinicaltrials.gov Identifier

    N/A, N/A

  • Duration of Study in the UK

    2 years, 4 months, 31 days

  • Research summary

    Dental fear and anxiety have been recognised to be an obstacle to successful treatment in children, impeding or even precluding quality dental care. Different surveys showed that the prevalence of dental anxiety in children and adolescents ranges around 5-33% all over the world. General anaesthesia (GA) is the most common modality for managing dental care for anxious children. However, the morbidity and mortality risks associated with GA are considerably higher compared with inhalation sedation. Although nitrous oxide/oxygen sedation is known to be safe and improve children’s ability to cope with dental treatment carried out under local anaesthetic, no good evidence exists as to the short and specifically long-term effects that the experience has on future levels of dental anxiety. Our aim of the study is to evaluate the short and long-term effects of nitrous oxide/oxygen sedation as compared with general anaesthesia on children’s future level of dental anxiety and acceptance of dental treatment. The study population is going to consist of 214 (107 in each group) 6-15 years old children with carious teeth treated under GA (exodontia) or nitrous oxide/oxygen sedation in Leeds Dental Institute. At the assessment visit the children’s anxiety score and sedation need will be recorded using p-IOSN for both sedation and GA group to ascertain the baseline anxiety score. We will also use an E4 Wrist band to record physiological parameters continuously during the dental treatment session. The anxiety score at the end of full course of treatment will be recorded using QTool which is a newly developed online questionnaire. It includes fMCDAS and ten questions on how the children feel after they had their treatment completed under GA or with inhalation sedation. Questionnaire will be sent 2 weeks, 3, 6 and 12 months after treatment is completed. Data from questionnaire QTool will be statistically analysed.

  • REC name

    East Midlands - Nottingham 1 Research Ethics Committee

  • REC reference

    21/EM/0008

  • Date of REC Opinion

    5 Mar 2021

  • REC opinion

    Further Information Favourable Opinion