A study protocol of a single-center investigator blinded randomized parallel group study to investigate the effect of an acclimatization visit on children’s behavior during inhalational sedation in a United Arab Emirates pediatric dentistry postgraduate setting as measured by the levels of salivary Alpha Amylase and Cortisol

Abstract

Introduction: Inhalation sedation is a proven safe method for reducing children’s dental anxiety and has been used worldwide for decades. There is controversy regarding the use of acclimatization or familiarization visits for dental sedation treatment pathways for children. This may increase acceptance to the treatment based on desensitization and acclimatization principles underpinning many behavior management techniques. This study aims to identify whether, an inhalation sedation acclimatization visit is effective in reducing the stress level in anxious children as measured by salivary Alpha Amylase and Cortisol levels.

Methods: The study is a single-center, single blinded, parallel group 2 arm clinical trial. Children in need of inhalation sedation aged 5 to 15 years from September 2019 through March 2020 attending the Postgraduate Pediatric Clinic at the Hamdan Bin Mohammed College of Dental Medicine, in Dubai, will be allocated randomly and equally to either: (1) Study group: children and parents would attend a visit for prevention and inhalation sedation will be introduced and tried; (2) Control group: children and parents would attend for prevention visit and discussion of inhalation sedation only. At the initial visit a salivary sample will be collected at the beginning of the visit and the sedation need score will be recorded using the pediatric indicator of sedation need. Treatment for both groups will commence at the second visit. Salivary samples will be collected 15 minutes before the start of the treatment and 15 minutes after the conclusion of the treatment. The following outcomes will be recorded: completion of dental treatment, anxiety scores at baseline and after treatment using Frankl rating behavior scale and physiological anxiety related changes will be recorded using salivary Alpha Amylase and Cortisol levels. Mean changes of physiologic anxiety levels and corresponding 95% confidence intervals will be determined to compare the 2 treatments (sedation with familiarization and sedation without familiarization).

Discussion: This is will be the first study to measure the effect of the acclimatization visit of nitrous oxide inhalation sedation on the level of physiological anxiety and the behavior of the pediatric patients during treatment.

Abbreviations: AAPD = American Academy of Pediatric Dentistry, ASA = American Society of Anesthesiologists, FBRS = Frankl behavior rating scale, GA = general anesthesia, IHS = inhalation sedation, IRB = Institutional Review Board, MBRU =Mohammed Bin Rashid University of Medicine and Health Sciences, MCDASf = modfied child dental anxiety scale-faces version, PI = principal investigator, p-SION = pediatric indicator of sedation need, SAA = salivary alpha amylase, SDCEP = Scottish Dental Clinical Effectiveness Programme, SPSS = statistical package for the social sciences, UAE = United Arab Emirates, UK = United Kingdom, USA = United States of America.