Children, Dental Anxiety
Conditions
Brief 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.
Interventions
None listed
Sponsors
Recep Tayyip Erdogan University Training and Research Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 8 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Dental Anxiety Score (MCDASf) | Baseline (T0) and immediately after local anesthetic administration (T2) | Dental anxiety will be assessed using the Modified Child Dental Anxiety Scale-faces version (MCDASf). Scores range from 8 to 40, with higher scores indicating greater dental anxiety. |
| Pain During Local Anesthetic Administration | Immediately after local anesthetic administration (T2) | Pain perception will be assessed using the Wong-Baker FACES Pain Rating Scale. Scores range from 0 (no pain) to 10 (worst pain imaginable). |
| Behavioral Response During Local Anesthetic Administration | During local anesthetic administration (T1) | Behavioral responses will be evaluated using the Sound, Eye, and Motor (SEM) scale during local anesthetic administration. Higher scores indicate greater pain- and anxiety-related behavioral responses. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Heart Rate | Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2) | Heart rate will be measured to evaluate the physiological response associated with local anesthetic administration. |
| Blood Pressure | Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2) | Systolic and diastolic blood pressure will be recorded to assess physiological changes associated with local anesthetic administration. |
| Peripheral Oxygen Saturation (SpO₂) | Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2) | Peripheral oxygen saturation will be measured using pulse oximetry to monitor physiological status during the procedure. |
| Body Temperature | Baseline (T0), during local anesthetic administration (T1), and immediately after local anesthetic administration (T2) | Body temperature will be recorded before, during, and after local anesthetic administration to evaluate physiological changes during treatment. |
Contacts
CONTACTdilara nil günaçar
PRINCIPAL_INVESTIGATORdilara nil günaçar
Recep Tayyip Erdoğan University Faculty of Dentistry
Outcome results
None listed