The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years

The Impact of Nitrous Oxide Sedation on Dental Fear and Anxiety Scores in Children Aged 6-10 Years: A Randomized Controlled Clinical Trial

Dental anxiety (DA) is highly prevalent among children undergoing dental procedures, with 50-80% experiencing fear that disrupts treatment and exacerbates oral health outcomes. While nitrous oxide (N₂O) sedation is widely used for its anxiolytic properties, evidence remains limited regarding its standardized efficacy in reducing pediatric fear and anxiety scores.

This study adopted a randomized controlled trial (RCT) design, strictly adhering to the CONSORT (Consolidated Standards of Reporting Trials) guidelines to ensure scientific rigor, reliability, and transparency.The sample size was calculated based on previous literature and preliminary pilot study results. Referring to the standard deviations of dental fear and anxiety scores in similar studies, the significance level (α) was set at 0.05, and the power (1 - β) was set at 0.85 (90% power). With an effect size of 0.4, the study anticipated significant differences in fear and anxiety scores between the experimental and control groups. Using statistical formulas and considering practical constraints, the estimated sample size required for each group was no fewer than 58 participants to ensure sufficient statistical power.

Inclusion Criteria:

• 1.Aged 6-10 years; 2.Classified as American Society of Anesthesiologists (ASA) physical status I-II; 3.Required dental treatments such as caries filling, pulp therapy, or tooth extraction; 4.Informed consent obtained from the child's guardian.

Exclusion Criteria:

• 1.Contraindications to nitrous oxide inhalation, such as severe cardiopulmonary dysfunction, intestinal obstruction, or pneumothorax; 2.Mental illness or intellectual disability that would hinder cooperation with assessments or treatment; 3.Received dental sedation or general anesthesia within the past month;