Clinical Trial

Effects of Topical Anesthetics on Pain and Anxiety in Children

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Summary
Dental anxiety and pain associated with local anesthetic injections are among the most common barriers to successful dental treatment in children. Topical anesthetic agents are widely used to reduce discomfort during needle insertion; however, evidence regarding the comparative effectiveness of different formulations remains limited. This prospective observational study aims to evaluate the effects of four routinely used topical anesthetic applications (benzocaine spray, benzocaine gel, lidocaine spray, and lidocaine gel) on pain and anxiety during local infiltration anesthesia in pediatric dental patients. The study will include 160 healthy children aged 6-8 years who require maxillary infiltration anesthesia for routine dental treatment. The choice of topical anesthetic will be determined by the treating clinician as part of routine clinical practice, and no additional intervention or treatment modification will be performed for research purposes. Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf), behavioral responses during local anesthetic administration will be evaluated using the Sound, Eye, and Motor (SEM) scale, and self-reported pain will be measured using the Wong-Baker FACES Pain Rating Scale. Physiological parameters, including heart rate, blood pressure, peripheral oxygen saturation (SpO₂), and body temperature, will be recorded before, during, and after local anesthetic administration. The findings are expected to provide evidence regarding the effectiveness of commonly used topical anesthetic formulations in reducing pain and anxiety during pediatric dental treatment and may contribute to optimizing behavior management strategies in clinical practice.
Trial Details
NCT Number NCT07733622
Lead Sponsor Recep Tayyip Erdogan University Training and Research Hospital
Conditions Dental Anxiety, Children
Enrollment 160 participants
Start Date 2026-07-30
Primary Completion 2026-09-01 (estimated)
Study Completion 2026-09-10 (estimated)
Updated on ClinicalTrials.gov 2026-07-29