Evaluation of the Effects of Different Topical Anesthetic Agents on Pain and Anxiety in Pediatric Patients
| Registry | NCT07733622 |
|---|---|
| Status | Not yet recruiting |
| Study type | Observational |
| Enrollment | 160 (Estimated) |
| Sponsor | Recep Tayyip Erdogan University Training and Research Hospital (Other) |
| Conditions | Dental Anxiety, Children |
| Dates | start 2026-07-30 (estimated), primary completion 2026-09-01 (estimated), completion 2026-09-10 (estimated), first posted 2026-07-29, last updated 2026-07-29 |
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All trials for Dental Anxiety All trials for Children
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Benzocaine Spray | Children who received benzocaine spray as the routinely selected topical anesthetic before local infiltration anesthesia. | ||
| Benzocaine Gel | Children who received benzocaine gel as the routinely selected topical anesthetic before local infiltration anesthesia. | ||
| Lidocaine Gel | Children who received lidocaine gel as the routinely selected topical anesthetic before local infiltration anesthesia. | ||
| Lidocaine Spray | Children who received lidocaine spray as the routinely selected topical anesthetic before local infiltration anesthesia. |
Sex: All, ages: 6 Years to 8 Years, accepts healthy volunteers
Inclusion Criteria: * Children aged 6 to 8 years. * Frankl Behavior Rating Scale score of 3 or 4. * No previous history of local anesthetic injection for dental treatment. * Requiring maxillary infiltration anesthesia for treatment of a maxillary second primary molar. * Requiring non-emergency, painless dental treatment. * Medically healthy children with no chronic systemic disease, mental disability, or physical disability. * Written informed consent obtained from a parent or legal guardian. Exclusion Criteria: * Frankl Behavior Rating Scale score of 1 or 2. * Physical or intellectual disability. * History of cardiovascular disease, diabetes mellitus, Graves' disease, epilepsy, hyperthyroidism, active infection, phenylketonuria, cardiovascular shock, otorrhea, or otitis. * Known hypersensitivity or allergy to benzocaine, lidocaine, or any component of the topical anesthetic formulations. * Emergency dental treatment or presence of dental pain requiring urgent intervention. * Chronic liver or kidney disease. * History of methemoglobinemia.