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NOT YET RECRUITING
NCT07733622

Effects of Topical Anesthetics on Pain and Anxiety in Children

Sponsor: Recep Tayyip Erdogan University Training and Research Hospital

View on ClinicalTrials.gov

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.

Official title: Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients

Key Details

Gender

All

Age Range

6 Years - 8 Years

Study Type

OBSERVATIONAL

Enrollment

160

Start Date

2026-07-30

Completion Date

2026-09-10

Last Updated

2026-07-29

Healthy Volunteers

Yes