Efficiency of ER:YAG laser therapy in combination with behaviour management technique in reducing anxiety among paediatric dental patients - a study protocol for a randomised clinical trial.

Introduction: When providing dental care to children with a high level of dental anxiety, the range of approaches is divided into two sections: use of behaviour management techniques (BMTs) and application of alternative methods for caries removal. In an attempt to reduce dental anxiety, they can be mixed and matched in accordance with the dentists' choice. Owing to its promoted advantages, erbium-doped yttrium aluminium garnet (Er:YAG) laser turns into an ideal alternative technique for hard dental tissue therapy in anxious paediatric patients. The aim of the study is to assess the efficacy of a modified version of the BMT 'Latent inhibition' in combination with Er:YAG laser for achieving a reduction of dental anxiety in paediatric dental patients.

Methods And Analysis: This is a protocol for a randomised controlled clinical trial. The participants will be children aged 6-9 years, requiring conservative treatment of occlusal carious lesion on a second primary molar. Patients will be randomly assigned to the experimental or control group via a computer-generated sequence. In both groups, 'Latent inhibition' will be used as an anxiety-management technique. In the experimental group, caries treatment will be performed with Er:YAG laser, whereas that in the control group it will be performed with conventional rotary instruments. Outcome measures will be dental anxiety felt before and after the treatment, reported by the patient on a modified version of the Faces Scale by LeBaron et al., and the dynamics of heart rate, registered during the treatment session, which will be measured with a mobile pulse oximeter. Data will be analysed by independent sample t-test and paired t-test (p˂0.05).

Ethics And Dissemination: The study protocol has been approved by the Committee for Scientific Research Ethics, Medical University-Plovdiv, Bulgaria (reference number P-2839, protocol of approval number 3/30.04.2015) and registered on a publicly accessible database. This research received institutional funding from the Medical University-Plovdiv, Bulgaria. The results will be presented through peer-reviewed publications and conference presentations.

Trial Registration Number: NCT04924452.