Pain, sensory acceptability, and treatment compliance following cryotherapy and topical anesthetics in children: A randomized clinical trial

This randomized clinical trial aimed to compare the effects of cryotherapy, anesthetic spray, and gel on pain, anxiety, physiological responses, taste acceptability, and treatment compliance in children aged 7–10 years undergoing their first dental treatment. 100 healthy children were randomly allocated into four groups: 10% lidocaine spray, 20% benzocaine gel, cryotherapy with distilled water cooled to +4 °C, and lidocaine spray cooled to +4 °C. Following topical application, buccal infiltration anesthesia was administered. Anxiety, pain, and physiological responses were assessed using the Modified Dental Anxiety Scale and Facial Image Scale, Wong-Baker FACES Pain Rating Scale, and pulse-oximeter. Taste acceptability and treatment compliance were evaluated using a three-point Hedonic Scale and the FRANKL Scale. Repeated Measures ANOVA, Mann-Whitney U, and Kruskal-Wallis tests were applied. No significant differences were observed among the groups in anxiety, pain, pulse rate, oxygen saturation, or taste acceptability (p > 0.05). Pulse rate increased from the pre-operative to the post-operative period in all groups (p = 0.006), with no significant group × time interaction. FRANKL scores were significantly higher in the cryotherapy-distilled water group compared with the gel and cooled-spray groups (p = 0.001), a finding considered exploratory. Pain and anxiety outcomes following cryotherapy did not differ significantly from those of the topical anesthetic agents, while treatment compliance was higher, suggesting that cryotherapy may be a promising non-pharmacological option, pending confirmation in non-inferiority trials. Trial registration ClinicalTrials.gov NCT07198022